Bab IV Yang Benar2 Fix

REVIEW SISTEMIK
Efektivitas metode pembongkaran dalam mencegah ulkus kaki

diabetik primer pada orang dewasa dengan diabetes: tinjauan
sistematis
Lisa Heuch1
Judith Streak Gomersall1,2

1The Joanna Briggs Institute, The University of Adelaide, Australia Selatan, Australia, 2Centre Keunggulan Penelitian pada
Penyakit Kronis Aborigin Penerjemahan dan Pertukaran Pengetahuan, Sekolah Kesehatan Masyarakat, Universitas Adelaide,
Adelaide, Australia Selatan, Australia
RINGKASAN EKSEKUTIF
Latar Belakang Insiden ulkus kaki yang berhubungan dengan diabetes meningkat. Banyak profesional perawatan kaki
merekomendasikan langkah-langkah offloading sebagai bagian dari strategi manajemen untuk modulasi tekanan berlebih untuk
mencegah perkembangan ulkus kaki diabetik (DFUs). Langkah-langkah ini mungkin termasuk padding, sol / perangkat orthotic
dan alas kaki. Ada kurangnya panduan berbasis bukti pada efektivitas pilihan pembongkaran yang berbeda untuk mencegah
ulserasi primer pada mereka dengan diabetes. Tujuan: Untuk mengidentifikasi, secara kritis menilai dan mensintesis bukti terbaik
yang tersedia tentang metode-metode offloading untuk mencegah perkembangan, dan mengurangi risiko, ulserasi kaki primer
pada orang dewasa dengan diabetes. Pertanyaan yang dibahas oleh review adalah: apa efektivitas metode pembongkaran dalam
mencegah DFU primer pada orang dewasa dengan diabetes?
Kriteria inklusi Jenis peserta Dewasa 18 tahun dan lebih tua dengan diabetes mellitus, tanpa memandang usia, jenis kelamin,
etnis, durasi atau jenis diabetes, tanpa riwayat DFU dan dalam pengaturan klinis akan dimasukkan. Jenis intervensi dan
pembanding Intervensi akan mencakup semua metode eksternal pembongkaran. Semua pembanding akan dipertimbangkan. Studi
yang menggunakan intervensi tidak dianggap praktek biasa dalam pencegahan DFU akan dikecualikan. Hasil Hasil utama adalah
ulserasi kaki primer. Hasil sekunder akan menjadi indikasi perubahan tekanan plantar. Jenis studi Ulasan ini akan
mempertimbangkan semua desain studi kuantitatif. Strategi pencarian Strategi tiga langkah untuk literatur yang diterbitkan dan
tidak dipublikasikan akan digunakan. Empat belas database akan dicari untuk studi dalam bahasa Inggris hingga November 2013.
Ekstraksi data Alat ekstraksi JBI-MAStARI digunakan untuk mengekstrak data yang relevan. Sintesis data Hasil dirangkum
menggunakan narasi dan tabel. Hasil Tiga penelitian yang menguji keefektifan dari empat intervensi pembongkaran berbeda
memenuhi kriteria inklusi. Ada bukti yang terbatas bahwa penggunaan sistem alas kaki (sepatu prototipe ditambah polyurethane
atau insole gabus) dapat
Korespondensi: Lisa Heuch, heuch.pod@gmail.com Tidak ada konflik kepentingan dalam proyek ini. DOI: 10.11124 / JBISRIR-
2016-003013
Database JBI dari Tinjauan Sistematik dan Laporan Implementasi © 2016 THE JOANNA BRIGGS INSTITUTE 236
© 2016 Joanna Briggs Institute. Penggandaan yang tidak sah dari artikel ini dilarang.
TINJAUAN SISTEMIK L. Heuch dan J. Streak Gomersall
mencegah istirahat di kulit; penggunaan perangkat ortotik kaku khusus dapat berkontribusi pada penurunan kelas dan jumlah
kapalan; dan sepatu yang diproduksi plus insole yang disesuaikan dapat mengurangi tekanan plantar dan oleh karena itu
mengurangi potensi risiko ulserasi kulit. Kesimpulan Ada bukti yang terbatas dan berkualitas rendah bahwa dalam populasi orang
dewasa dengan diabetes tanpa riwayat DFU, penggunaan alas kaki dengan perangkat orthotic yang disesuaikan atau prefabrikasi
dapat memberikan beberapa pengurangan tekanan plantar dan karena itu membantu untuk mencegah DFU primer. Kurangnya
bukti tentang efektivitas relatif dari opsi-opsi offloading yang berbeda.
Kata kunci Diabetes; ulkus diabetik; ulkus kaki; pembongkaran; pencegahan
Latar belakang D
iabetes masalah di mellitus Australia (DM) dan berada di tingkat publik global utama. kesehatan Satu penelitian
memperkirakan bahwa prevalensi dunia akan menjadi 382 juta pada tahun 2030,1,2 sementara Organisasi Kesehatan
Dunia telah memperkirakan prevalensi 366 juta pada tanggal ini. Hingga 50% dari mereka yang menderita diabetes
akan mengembangkan komplikasi terkait dengan 3. Diabetes dan komplikasi terkait di Australia diperkirakan
menelan biaya hingga $ 6 miliar per tahun untuk DM tipe 2 (T2DM) dan $ 570 juta per tahun untuk DM2 tipe 1.
Ulkus kaki, hasil utama dari minat dalam Ulasan ini, adalah salah satu komplikasi yang paling umum, dan mungkin
dapat dicegah, dari kedua jenis DM.
Ulkus kaki dapat berkembang karena serangkaian perubahan patologis yang terkait dengan peningkatan kadar
glukosa darah pada tingkat seluler dan jaringan. Kerusakan vaskular dan / atau neurologis mempengaruhi perfusi
oksigen yang menyebabkan respons penyembuhan yang lebih buruk terhadap trauma lokal, misalnya, tekanan.5,6
Faktor-faktor yang berkontribusi pada perkembangan ulkus kaki diabetik (DFU) dan jalur yang mengarah pada
pengembangan DFU terdokumentasi dengan baik. Ringkasan dari jalur ini disajikan pada Gambar 1.
Neuropati sensori di ekstremitas bawah mengakibatkan hilangnya mekanisme umpan balik pelindung tubuh
sebagai respons terhadap rasa sakit atau sentuhan yang mengakibatkan non-deteksi trauma minor seperti melepuh
atau lecet.7 , 8 neuropati Motor dapat mempengaruhi keseimbangan (propriocep- tion) dan kesadaran spasial, yang
memberikan kontribusi terhadap perubahan gaya berjalan. Hal ini dikombinasikan dengan perubahan struktur kaki,
hilangnya volume otot dan kekuatan otot di kaki dan pergelangan kaki (terkait dengan konduktansi saraf yang
buruk) menyebabkan gaya abnormal selama berjalan, yang dapat menyebabkan perkembangan Gesekan
Database JBI dari Ulasan dan Implementasi Sistematis. Laporan © 2016 THE JOANNA BRIGGS INSTITUTE 237
atau lesi terkait tekanan seperti kalus atau jagung.5,7,9-11 Neuropati otonom berkontribusi pada kulit menjadi
kering dan tipis dan lebih rentan terhadap kerusakan. Selain itu, disfungsi mikrovaskuler berkontribusi terhadap
penurunan perfusi jaringan yang menyebabkan berkurangnya oksigenasi jaringan, yang dapat menyebabkan
peningkatan kerentanan terhadap stres mekanis.5,10-12 Tiga area neuropati ini merupakan kontributor utama
terhadap perkembangan ulkus diabetik. dan kegagalan penyembuhan luka berikutnya.5
Faktor utama lain yang diidentifikasi dalam literatur sebagai kontribusi terhadap perkembangan ulkus kaki pada
pasien dengan diabetes adalah tekanan. Meningkatnya tekanan dan gaya geser yang berhubungan dengan perubahan
struktur kaki menghasilkan hiperkeratosis yang muncul sebagai kalusus.10,13-15 Area kalus plantar, khususnya,
biasanya terlihat ketika tekanan yang berkaitan dengan gaya berjalan dan alas kaki tidak normal. Sebuah studi oleh
Rich dan Veves13 menunjukkan korelasi positif antara tingkat keparahan neuropati, '' tekanan kaki depan tertinggi ''
(13,85) dan ulserasi. Jika tekanan pada area kulit yang terkena dan kalus berikutnya yang berkembang tidak
berkurang dengan pembongkaran dan / atau debridemen mekanis, tekanan yang tidak diteruskan akan terus
meningkat dan menyebabkan trauma lokal pada jaringan. Jaringan yang mengalami trauma bisa tidak terdeteksi
untuk beberapa waktu. Karena kurangnya rasa sakit / sensasi umpan balik, orang tersebut mungkin tidak menyadari
bahwa cedera telah terjadi dan bahkan pada pemeriksaan kaki mereka, kerusakan jaringan mungkin tidak terlihat
jika tersembunyi di bawah kalus.
Ulkus neuropatik diabetik biasanya berkembang di area tekanan berlebih pada permukaan plantar kaki atau pada
permukaan dorsal jari kaki yang salah arah. Sementara beberapa penulis berbeda mengenai situs yang paling umum
untuk DFU, ada bukti untuk menunjukkan hubungan yang pasti antara plantar yang lebih tinggi
REVIEW LATAR L. Heuch dan J. Streak Gomersall
Tingkat glukosa darah yang terkait dengan DM
Perubahan neurologis Perubahan
vaskular
Neuropati sensoris Neuropati
motorik Autonom neuropati Perfusi jaringan yang buruk kerentanan kulit terhadap trauma Kehilangan umpan balik
Perubahan gaya berjalan karena
perubahan kulit terkait
mekanisme oksigenasi dalam
volume otot
ke DM (kekeringan,
respons penyembuhan
terhadapnyeri
kekuatan
penipisan)
risiko iskemia dan / atau
tekanan
Perubahan padakaki
kerentananterhadap struktur misalnya bunion,
trauma cakar jari kaki
penyembuhan Perubahan gaya berjalan
Gaya abnormal menyebabkan
Kulit kering menjadi tekanan lokal yang
rentan terhadap retak - tekanan plantar
meningkatkan peluang - tegangan geser
infeksi
Callus / corn berkembang di
daerah rawan Infeksi misalnya daerah sub-metatarsal, jari-jari kaki cakar dorsum, bunion
Tekanan yang terus-menerus atau tidak henti-hentinya dapat menyebabkan trauma lokal pada kulit atau ti ssue di bawah kalus /
jagung
Ulkus kaki diabetik
Gambar 1: Diagram alir menunjukkan jalur kausal untuk mengembangkanulkus kaki diabetik
tekanan, terutama di bawah hallux, gabungan
Di antara orang yang didiagnosis menderita DM,
wilayah metatarsal dan daerah tumit16,17 dan cacat-
risiko seumur hidup berkembang ulkus kaki diperkirakan
ities yang mempengaruhi tekanan yang lebih tinggi secara lokal.18
menjadi setinggi 15% .4 Risiko berkembangnya Ulkus bisa
mendalam dan dapat memungkinkan probing dari
DFU berikutnya setelah penyembuhan ulkus primer ke
tulang di bawahnya. 6,9,19 Ulkusdiabetik
ulkusbervariasi; Namun, ada sedikit keraguan bahwa
didefinisikan oleh Apelqvist et al.9 sebagai '' lesi melalui
risiko untuk mengembangkan DFU berikutnya adalah
ketebalan penuh dari dermis (kelas Wagner
meningkat. Banyak penulis mengutip DFU sebelumnya
sebagai satu 1 ) ''. 9 (p.486) Untuk keperluan tinjauan ini, kecuali
faktor risiko untuk ulserasi berikutnya.7,21-23 Hun - jika
tidak dinyatakan, istilah ulkus kaki mengacu pada ''
t22 yang melaporkan bahwa kerabat risiko (RR) daerah
berkembang dari kehilangan kulit akibat pasokan darah yang buruk
DFU kedua adalah 1,6 (95% CI 1,2-2,3) dengan dan /
atau mengurangi fungsi saraf diekstremitas bawah
tingkat kekambuhan 5-tahunsebesar 66%. Dubsky ́ et
al.23 ditemukan disebabkan oleh diabetes mellitus '' sebagaimana didefinisikan oleh Cochrane
bahwa dalam tindak lanjut dari subkelompok Eurodiale,
lebih banyak Kelompok Luka. 20
dari setengah peserta (57,5%) telah mengembangkan
JBI Database of Systematic Ulasan dan Laporan Pelaksanaan © 2016 THE JOANNA BRIGGS INSTITUTE 238
DFU kedua setelah 3 tahun. Studi Eurodiale,
Laporan Implementasi, Perpustakaan Cochrane yang
diterbitkan pada 2008,24 merupakan studi kohort prospektif
Ulasan Sistematik, PubMed, Scopus, Embase, dari 1.088
pasien dengan DFU, dengan atau tanpa
Direct Science, Google Cendekia dan CINAHL) con-
penyakit arteri perifer (PAD). Penelitian, yang
dilakukan pada tahun 2012 mengungkapkan penelitian
primer yang besar menyalurkan seluruh 14 pusat Eropa, menemukan bahwa
literatur untuk menarik serta enam keberadaan SRs PAD
yang ada memprediksi hasil yang lebih buruk yang
berkaitan dengan pertanyaan tentang efektivitas tidak
terkait untuk penyembuhan, khususnya,dampak negatif
pemuatanuntuk mencegah ulkus kaki pada orang yang
hidup dengan infeksi pada kelompok ini.24
diabetes.31 Ulasan yang teridentifikasi adalah: Ulkus kaki
yang tidak sembuh dan berulang sering menyebabkan
ulasan pertama kali diterbitkan pada tahun 200032 yang
menginvestigasi - untuk amputasi.5 Hunt22 melaporkan risiko 12% dari
efektivitas metode terjaga keamanannya untuk kedua
pencegahan dalam waktu 5 tahun. Perry et al.25 laporan
tion dan pengobatan DFUs. Intervensi bahwa risiko
amputasi pada diabetisi sudah
dipertimbangkan dalam tinjauan termasuk eksternal
off-ke 15 kali lipat dari populasi umum. MetodeLepantalo
pemuatanuntuk pencegahan, dan kontrol total al.5
menemukan bahwa 85% diabetes terkait amputasi amput
(TCC) dan dressing untuk pengobatan. Tions adalah
hasil dari ulkus diabetes.Trautner
Temuan utamadari tinjauan ini yang termasuk et al.26
menyebutkan bahwa RR dari studi yang diamputasi terkait
uji kontrol terkontrol (RCT) hanya dengan diabetes
adalah 22 kali lebih besar daripada di non-
(tidak ada kisaran tanggal publikasi yang dilaporkan)
adalah: populasi diabetes . Selain itu, Schofield et al.27ortostik
meskipundalam sepatu telah terbukti menentukan
bahwa setelah ekstremitas bawah ampu
dalam mengurangi tekanan manfaat dari tingkat
kelangsungan hidup 5 tahun bagi mereka dengan diabetes,
perangkat ortotik tertentu tidak jelas. ; penggunaannya
serendah 31,9%, yang mendukung serupa
sepatu lari sebagai intervensi untuk mengurangi
temuan oleh Aulivola et al.12
tekanan diperlukan evaluasi lebih lanjut; Ada praktik
manajemen terbaik saat ini untuk mencegah
tidak ada RCT yang mengevaluasi pejalan kaki yang
dapat dilepas. DFU termasuk pemantauan reguler terhadap integritas kulit
(RCW); dan sementara RCT dari TCC menunjukkan
status efektif dan neurovaskular, serta debridisasi reguler
, bukti terbatas. jagung dan kalus.9 Metode-metode ini
adalah
SR lain, yang diterbitkan pada tahun 2008,29 memiliki
tujuan yang umum digunakan bersama dengan modif tekanan
untuk meninjau bukti yang tersedia tentang
penggunaan lasi, sering disebut sebagai offloading, yang
alaskaki dan pembongkaran intervensi untuk
intervensi kepentingan dalam ulasan ini. Offloading sebagai
pencegahan DFUs serta pengobatan untuk intervensi
digunakan untuk mencegah perkembangan
DFUs yang ada, dan pengurangan tekanan plantar dari
ulkus dan untuk mencapai hasil terbaik jika
pada mereka dengan diabetes. Semua ulkus studi
kuantitatif terjadi.28,29restriksi
desain dianggap tanpabahasa- Langkah-langkah
offloading dapat didefinisikan sebagai '' setiap
tions, dan pencarian termasuk semua tanggal sebelum
mengukur untuk menghilangkan ... tekanan abnormal poin
1 Mei 2006. Berkenaan dengan keefektifan untuk
mempromosikan penyembuhan atau mencegah terulangnyadiabetes
pembilasanuntuk mencegah borok kaki pada orang
yang hidup ulkus kaki '' .30 (hal.35) Intervensi mekanis eksternal
dengan diabetes, tinjauan menemukan bahwa ada
tions untuk membongkar muatan tinggi. daerah tekanan termasuk, tetapi
tidak cukup bukti yang berkaitan dengan primer tidak
terbatas pada, padding melekat langsung ke
pencegahan ulserasi pada mereka dengan DM; sol
kaki, empuk atau yang disesuaikan, yang disesuaikan atau
dan lebih banyak penelitian diperlukan pada
perangkat ortotik yang efektif-prefabrikasi, alas kaki sepatu yang disesuaikan
dan intervensi pembongkaran untuk dan sepatu bersol
rocker. Penggunaan metode offloading untuk
mencegah dan menyembuhkan DFU. mencegah ulkus
kaki terjadi pada orang yang hidup
Sebuah SR yang diterbitkan pada tahun 200922
memeriksa bukti dengan diabetes dipilih sebagai topik untuk sistem ini -
dari SR lain dan RCT dengan tujuan peninjauan atic
(SR) karena perawatan kaki anekdot yang
menentukan efektivitas intervensi di profesional
mengidentifikasi intervensi offloading sebagai
mencegah ulkus kaki dan amputasi pada orang-orang
intervensi yang kurang dimanfaatkan dan yang
dengan diabetes dan efek pengobatan di mungkin
lebih baik dari orang yang nyaman secara klinis,
diabetes dan DFU. Kriteria pencarian keterjangkauan
pasien dan perspektif kenyamanan.
termasuk SR dan RCT yang diterbitkan dalam pencarian
sepintas daripustaka yang ada
bahasa, setidaknya satu-buta, dan mengandung
(Database JBI dari Tinjauan Sistematis dan
lebih dari 20 orang di antaranya lebih dari 80%
JBI Database dari Ulasan Sistematis dan Laporan Implementasi © 2016 JoananINSTITUTE 239
Briggs Institute© 2016 Joanna Briggs Institute Penggandaan yang tidak sah dari artikel
ini dilarang
ditindaklanjuti.Hari pencarian berasal dari tahun 1966
terbatas dan dokter mungkin tidak yakin apa yang harus
dilakukan. 2007 di berbagai database.Bersama
sekali neuropati hadir.RCTs menghormati pencegahan
DFUs, penulis ditemukan
ditinjau tidak mendukung '' peningkatan pasien tidak
cukup bukti mengenai pemakaian
kation, keterlibatan perawat intensif, khusus- sepatu
terapeutik atau peningkatanpasien
edukasiedued''35 (hal.1044) atau intervensi bedah kation
untuk pencegahan. Penulis menemukan bahwa
seperti debridemen t hiperkeratosis, bedah ada beberapa
bukti yang menunjukkan bahwa skrining
reseksi tulang pada titik tekanan berlebih atau dari
mereka yang berisiko dan rujukan berikutnya untukkhusus
dekompresi saraf. Ulasan yang ditentukan untuk klinik
kaki mungkin bermanfaat. Untuk pengobatan
yang gagal menghindari suhu kaki plantar dari DFU,
penulis menemukan bukti bahwayang didukung
terapibermanfaat pada mereka dengan diabetes tetapi
penggunaan TCC dan RCW untuk pengobatan
menyarankan bahwa validasi pada populasi lain tetapi
tidak cukup bukti untuk mendukung penggunaan
adalah dibutuhkan. busa yang sudah dikeringkan atau
setengah sepatu penekan tekanan. Penulis juga memeriksa bukti yang berkaitan dengan penggunaan
SR saat ini dilakukan untuk mengidentifikasi setiap
manusia setara kulit, faktor pertumbuhan,hiper-
penelitiantambahan yang diterbitkan sejak melakukan terapi
oksigen baric dan dressing luka.
ulasan ini. Bukti tambahan tentang efek- Ulasan yang
diterbitkan pada tahun 201033 dianggap RCT tiveness ofoffloading
untuk mencegah ulkus kaki saja, tidak menerapkan
pembatasan bahasa dengan
bantuan menginformasikan bimbingan berbasis bukti untuk
praktisi mencari rentang tanggal hingga 2008. Ulasan ini
dan menambahkan ke bukti yang ada. menjauhkan bukti pada
efektivitas kompleks versus intervensi tunggal, penggunaanbiasa
perawatan tujuan Tinjauanatau intervensi kompleks alternatif
untuk mencegah DFUs. Tidak ada bukti berkualitas tinggi mengenai intervensi kompleks versus tunggal ditemukan.
Ulasan yang diterbitkan pada tahun 201134 yang melihat pada
Database JBI tentang Tinjauan Sistematis dan Laporan Implementasi © 2016 THE JOANNA BRIGGS INSTITUTE 240
Protokol untuk ulasan ini31 memiliki tujuan untuk mengidentifikasi, secara kritis menilai dan mensintesis bukti
terbaik yang tersedia pada metode pemindahan untuk mencegah DFU pada orang dewasa dengan diabetes. RCT,
non RCT, tindak lanjut yang diterbitkan dan panjang-
Selama pencarian basis data awal sebelum studi
formularisasi hingga tahun 2008 difokuskan pada evaluasi efektivitas insoles yang berbeda untuk pencegahan DFUs.
Temuan menentukan bahwa sementara ada beberapa nilai untuk menggunakan sol untuk
lating strategi pencarian, itu menjadi jelas bahwa ada sejumlah besar studi yang terkait dengan penggunaan
offloading untuk membantu dalam penyembuhan DFU saat ini dan pencegahan DFUs berikutnya. Telah dicatat
bahwa pencegahan ulkus, penggunaannya bersamaan dengan
ada beberapa penelitian yang berfokus pada pencegahan
strategi pencegahan bagi mereka yang berisiko terhadap DFU, patut diselidiki lebih lanjut. Para penulis tidak dapat
membuat rekomendasi mengenai spesifik yang terkait dengan berbagai jenis sol.
DFU primer. Karena SR sudah ada yang berkaitan dengan penggunaan offloading untuk penyembuhan dan / atau
pencegahan DFUs berikutnya, maka diputuskan untuk menyimpang dari protokol a priori31 dan fokus khusus pada
Rekomendasi untuk penelitian masa depan termasuk
pencegahan DFU primer. perbandingan berbagai sol dan
yang berbeda
Oleh karena itu, tujuan dari SR ini adalah untuk
mengidentifikasi, mode aksi, sol prefabrikasi versus yang disesuaikan serta umur panjang perangkat. Pada tahun
2011,35 ulasan telah diterbitkan yang secara
kritis menilai dan mensintesis bukti terbaik yang tersedia tentang metode-metode pembongkaran untuk mencegah
perkembangan, dan mengurangi risiko, pada kaki primer hanya menyisakan RCT, diterbitkan antara 1 Januari,
ulserasi pada orang dewasa dengan diabetes. . 1960 dan 30
April 2010, dan memiliki tujuan yang
lebih spesifik, pertanyaan yang dibahas oleh efektivitas
investigasi intervensi untuk pencegahan DFU masa depan: baik primer maupun sekunder. Para penulis
mempertimbangkan beberapa metode eksternal mech-anical dari offloading serta
review adalah: apa keefektifan metode pembongkaran untuk mencegah DFU primer pada orang dewasa dengan
diabetes?
intervensi bedah dan juga intervensi yang
Kriteria inklusi dipandu oleh pengukuran kaki plantar
Jenis suhu peserta. Temuan dari tinjauan menunjukkan
Ulasan
saat ini mempertimbangkan penelitian yang memasukkan
bahwa bukti untuk intervensi pembongkaran terbanyak adalah
orang dewasa yang berusia 18 tahun dan lebih tua yang didiagnosis dengan DM
SYSTEMATIC REVIEW L. Heuch dan J. Streak Gomersall
tanpa memandang usia, jenis kelamin dan etnisitas, durasi
saat itu dilakukan di semua basis data yang termasuk.
diabetes atau jenis diabetes tanpa riwayat
Ketiga, daftar referensi dari semua laporan yang
diidentifikasi dan ulserasi kaki.
artikel dicari untuk studi tambahan. Studi yang diterbitkan dalam bahasa Inggris diterbitkan hingga dan termasuk
Jenis intervensi dan pembanding
November 2013 dipertimbangkan untuk dimasukkan.
Ulasan saat ini dianggap studi yang dievaluasi
Database yang dicari adalah PubMed, Cochrane
efektivitas semua metode offloading dan strat-
Database Ulasan Sistematis, CINAHL, egies untuk
mencegah ulkus kaki, termasuk, tetapi tidak
EMBASE, SCOPUS dan Google Scholar. Pencarian
terbatas pada, padding (di-shoe dan dilampirkan secara langsung
untuk studi yang tidak dipublikasikan termasuk Cochrane
- Proto-to the foot), sol yang disesuaikan
, cols ortotik khusus, Research and Trials Register,
Clinicaltrials.gov, perangkat dan alas kaki khusus.
NHS Research Register, REGARD (basis data Mengenai
pembanding, tinjauan
ESRC). Pencarian pencarian literatur abu-abu termasuk
penelitian yang mempertimbangkan keefektifan
Google Scholar, SIGLE, Mednar dan WorldWideS - salah
satu metode offloading dibandingkan dengan yang lain untuk
cience. Kata kunci awal yang digunakan adalah:
offloading, pad-mencegah kaki ulkus serta satu offloading
ding, dewasa, pencegahan, diabetes, ulkus kaki, intervensi
diabetes dibandingkan dengan pembanding lainnya,
ulkus dan juga istilah MeSH di atas ketika pencarian-
termasuk pengobatan tradisional oleh ahli penyakit kaki.
ing PubMed. Strategi pencarian yang digunakan untuk
PubMed Studies yang menggunakan intervensi tidak
terkondisi dan database CINAHL disediakan dalam
Appendix I. praktek biasa yang dipinggirkan dalam pencegahan DFU
Fokus pencarian awal adalah untuk literatur yang
dikesampingkan.
ing '' ulkus kaki diabetik ''; Namun, istilah pencarian dimodifikasi untuk memasukkan '' ulkus kaki neuropatik '' Hasil
untuk menangkap semua bukti yang tersedia. Hasil utama
yang menarik dalam tinjauan ini adalah pencegahan DFU primer.
Metode review Hasil sekunder adalah indikasi
Penilaian perubahan kualitas metodologis pada tekanan
pada kulit kaki saat ada
Pada penyelesaian proses pencarian, dua pengulas adalah
bukti kuat yang menunjukkan hubungan antara
(LH dan JT) secara independen menilai tiga pejantan -
Perubahan struktur kaki danberikutnya
iesmenggunakan Daftar Periksa Penilaian JBI untuk
perubahan tekanan pada kulit diatasnya dalam hubungan
Randomized Control / Pseudo-Randomized Trial untuk
neuropati terkait diabetes, dan potensi untuk
(Appendix II). Karena jumlah kecil perkembangan
ulserasi kulit yang memenuhi syarat. Semua metode
penelitian, diputuskan sebelum penilaian kritis untuk
mengukur perubahan tekanan dipertimbangkan,
termasuk penelitian yang mencetak empat atau lebih dan
untuk mencatat termasuk tetapi tidak terbatas pada,visual, mekanis atau
kelemahanmetodologis untuk menarik yang
terkomputerisasi.
implikasi dalam interpretasi hasil.penelitian
Jenis penelitian
kualitasdiklasifikasikan sebagai tinggi (7-10), sedang (5-6) atau miskin (1-4). Semua desain studi kuantitatif
dianggap
Tidak ada perselisihan antara peninjau termasuk studi
kontrol secara acak, studi kuasi-pengalaman, studi kohort dan kontrol kasus serta studi deskriptif termasuk seri kasus
dan
Basis Data JBI dari Tinjauan Sistematik dan Laporan Implementasi © 2016 THE JOANNA BRIGGS INSTITUTE 241
berkaitan dengan proses atau hasil penilaian kritis.
sebelum dan sesudah belajar.
Ekstraksi Data
Strategi Pencarian
Data diekstraksi dari tiga makalah yang termasuk dalam tinjauan menggunakan Formulir Ekstraksi Data JBI untuk
Strategi pencarian tiga langkah digunakan dalam
Studi Eksperimental / Observasional ini, yang merupakan
tinjauan untuk menemukan penelitian yang dipublikasikan dan tidak dipublikasikan.
alat ekstraksi data standar dari JBI-MAS- Pencarian awal
terbatas untuk MEDLINE dan CINAHL
tARI (Lampiran III). dilakukan diikuti oleh analisis kata-
kata teks yang terdapat dalam judul dan abstrak, dan dari
data sintesis istilah indeks yang digunakan untuk
menggambarkan artikel.kedua
Perbedaandalam populasi, intervensi, komparatif
menggunakan semua kata kunci yang teridentifikasi dan istilah indeks
tors dan hasil dari studi yang disertakan tidak
REVIEW SISTEMIK L. Heuch dan J. Streak Gomersall
memungkinkan untuk perbandingan langsung, dan karena itu meta
tidak dapat diambil dalam teks lengkap. Daftar analisis itu
tidak mungkin. Akibatnya, hasil
studi yang dikeluarkan 54 dengan alasan untuk
pengecualian mereka dari tiga studi disintesis oleh hasil
sion disajikan dalam Lampiran IV. Tidak ada tambahan
menggunakan narasi dan tabel.
studi diidentifikasi dari pencarian referensi studi termasuk dan karenanya hanya tiga penelitian yang Hasil
termasuk dalam tinjauan. Deskripsi studi Hasil dari
proses seleksi pencarian dan studi
Karakteristik studi termasuk disajikan pada Gambar 2.
Sebanyak 2465 berpotensi
Langsung di bawah ini, fitur utama dari studi yang
relevan termasuk diidentifikasi dari database,
studi dirangkum. Lampiran V menunjukkan yang utama
yang 2358 dikeluarkan pada evaluasi
karakteristik studi yang termasuk. judul dan abstrak
karena mereka jelas tidak memenuhi kriteria untuk seleksi. Ini meninggalkan 107berpotensi
studi Desainrelevan yang 28 adalah duplikat dan
Tiga studi termasuk satu RCT10 dan dua telah dihapus.
Dari sisa 79 abstrak, sebuah
studi kuasi-eksperimental, salah satunya adalah 22
tambahan dikeluarkan pada pemeriksaan rinci
non-acak studi silang36 dan satu prospek abstrak
meninggalkan 57 studi untuk pengambilan teks penuh
sebelum dan setelah penelitian. 37 dan ulasan. Dari 57
penelitian, 47 dikeluarkan pada tinjauan teks lengkap karena tidak memenuhi kriteria inklusi
Pengaturan untuk populasi (42) dan intervensi (5), tiga
dari tiga studi, satu dilakukan di Amerika Serikat, 36
dikeluarkan karena tidak cukupnya data tersedia
satu di Jerman37 dan satu di Australia.10 Ketiganya dari
teks lengkap dan empat dikeluarkan karena studi
penelitian ditetapkan di klinik medis atau yang serupa.10,36,37
Makalah yang berpotensi relevan yang diidentifikasi dari pencarian basis data elektronik Diterbitkan (n = 1844 ) Tidak
dipublikasikan (n = 154) Literatur abu-abu (n = 467) Total (n = 2465)
Makalah dikecualikan setelah evaluasi abstrak (n = 2358)
Abstrak diambil dari basis data elektronik (n = 107)
Duplikat dihapus (n = 28)
Abstrak ditinjau (n = 79)
Makalah dikecualikan berdasarkan abstrak (n = 22)
Makalah diambil untuk pemeriksaan teks lengkap (n = 57)
Makalah dikecualikan yang tidak sesuai dengan kriteria inklusi Populasi salah: (n = 42) Intervensi yang salah: (n = 5 )
Studi kritis dinilai (n = 3)
Tidak cukup data: (n = 3) Teks lengkap tidak tersedia: (n = 4) Total (n = 54)
Studi yang disertakan (n = 3)
Dari: Moher D, Liberati A, Tetzlaff J, Altman DG, Grup PRISMA (2009). Item Pelaporan Pilihan untuk Tinjauan Sistematis dan
Analisis-Meta: Pernyataan PRISMA. PLoS Med 6 (6): e1000097. doi: 10.1371 / journal.pmed1000097 Gambar 2: Diagram alir
untuk mencari dan mempelajari pilihan
Basis Data JBI dari Tinjauan Sistematis dan Laporan Implementasi © 2016 THE JOANNA BRIGGS INSTITUTE 242
REVIEW SISTEMIK L. Heuch dan J. Streak Gomersall
Tanggal penerbitan untuk studi yang dipilih berkisar
Satu penelitian hanya melibatkan peserta dari 1995
hingga 2001. Semua penelitian diterbitkan
T2DM, 37 dan dua tidak melaporkan peserta dalam
bahasa Inggris.
betes type.10,36
Masing-masing dari tiga penelitian melaporkan
informasi Intervensi dan pembanding
mengenai durasi DM. Satu studi36 melaporkan Secara
keseluruhan, empat intervensi dan dua pembanding
44% peserta yang memiliki DM selama lebih dari 10
diperiksa dalam penelitian, yang ditunjukkan dalam beberapa
tahun, yang lain melaporkan durasi DM di antara Tabel 1.
Semua penelitian menguji efektivitas
peserta sebagai 8,4 Æ 7,5 years10 dan yang ketiga
intervensi offloading sebagai perawatan mandiri.
melaporkan durasi DM sebagai 13,0 Æ 6,3 tahun .7
Glycated hemoglobin (HbA1c), ukuran peserta
kadar glukosa darah rata-rata selama tiga bulan, Usia
peserta berkisar dari 4536 ke 8436
hanya dilaporkan dalam satu studi dan dilaporkan tahun,
dan usia rata-rata semua peserta dalam
untuk kedua kelompok peserta pada awal dan setelah
studi yang dimasukkan adalah 65,5 tahun.
12 bulan.37 Jumlah peserta studi berkisar dari
Jenis Kelamin dilaporkan dalam semua penelitian.
Satu penelitian 2010 hingga 8137 dengan total 105 di antara tiga
peserta laki-laki yang hanya digunakan.36 Dalam studi
yang tersisa. Seperti yang ditunjukkan pada Tabel 2, study37 yang
mempelajari, rasio laki-laki terhadap perempuan
dilaporkan menguji efektivitas dari pembuatan
sebagai sepatu 1: 310 dan (kurang-lebih) 3: 5.37 dengan
sol yang disesuaikan dibandingkan dengancon-
studiOne melaporkan berat badan peserta: 75 Æ 10
alas kaki ventura adalah yang terbesar. Penelitian 10 bahwa
kg, tetapi tidak melaporkan indeks massa tubuh (BMI)
.10 Pemeriksaan keefektifan darikaku yang disesuaikan
dua studiyang melaporkan BMI (28,6 Æ 3,936 dan
perangkat ortotik adalah yang terkecil.
26,45 Æ 3,737) tidak melaporkan berat badan.
Tabel 1: Intervensi dan pembanding untuk penelitian yang termasuk
Referensi Intervensi (s) Komparator Reiber et al.36 Sistem alas kaki terdiri dari
Tidak Ada 1. Prototipe sepatu þ insole gabus khusus 2. Sepatu
prototipe þ insulasi polyurethane standar yang sudah terbentuk Intervensi kedua dilaksanakan untuk 4 minggu
masing-masing (secara acak) awalnya, kemudian peserta memilih salah satu dari intervensi untuk dipakai selama 4
bulan tersisa untuk total 6 bulan. Pengukuran tindak lanjut dicatat pada setiap pergantian dan setelah 6 bulan
Colagiuri et al. 10 Perangkat orthotic rigid Perawatan tradisional oleh dokter bedah
termasuk pengupas kulit hiperatolik, pelembab dan bantalan hipoalergenik Lobmann et al.37 Sepatu yang diproduksi
þ sol yang disesuaikan
( sol yang diproduksi menggunakan kombinasi etilen-vinil-asetat, busa polythene, elastotor dan silikon)
Database JBI dari Ulasan Sistematis dan Laporan Implementasi © 2016 THE JOANNA BRIGGS INSTITUTE 243
Alas kaki konvensional (PVC shoe)
PVC, polyvinyl chloride.
Tabel 2: Peserta dalam studi termasuk

Usia
rata-rata Durasi rata-rata
Referensi Nomor
(tahun) Jenis kelamin
diabetes Reiber et al.36 24 66
24M / 0F Tidak dilaporkan Colagiuri et al.10 20 66 5M / 15F 8.4 tahun Lobmann et al.37 81 64.5 31M / 50F 13
tahun
Dua dari studi melaporkan pengukuran dari
dua studi yang tersisa mempresentasikan data untuk
neuropati; namun, perbedaan dalam pengukuran-
perubahan tekanan, skala hasil sekunder yang digunakan
digunakan membuat perbandingan langsung
dari minat. Temuan
sulit.10,36 Satu penelitian 10 yang menguji efektivitas
Tidak ada penelitian yang melaporkan pilihan gaya hidup /
perangkat ortotik kaku yang disesuaikan dibandingkan
dengan perilaku peserta atau intervensi lain
pengobatan tradisional oleh podiatrist digunakan
observatio- (misalnya fisioterapi) untuk pasien, yang mungkin memiliki
ukuran akhir dan fokus pada perubahan pada kalus
mempengaruhi hasil, dan merupakan masalah dalam
jumlah dan tingkatan untuk mengukur tekanan. Kalus
dalam diskusi.
skin of the foot is recognized by foot care professionals as an indication of excess or increased Outcomes
pressure in the area.10,13-15 The study used a visual No
studies were identified with a specific primary
method to categorize grades of callus using before
outcome of development of a DFU. The one study36
and after photographs. The photographs were that
examined the effectiveness of a footwear system
assessed by the consensus of three authors who
(prototype shoe plus customized cork insole or pre-
viewed them together and were blinded to subject formed
polyurethane [PU] insole) had a primary
identification, date of the photograph and interven-
outcome of a break in cutaneous barrier as its out-
tion group. The classification system is detailed in come.
Skin breakages can lead to the development of
Appendix V. No validation information for this a
DFU4,7,8,13,38 and hence this study offers some
measurement system was found. evidence, if very limited
(only 24 participants and
One study37 measured changes in skin pressure
methodological weaknesses), for the primary out-
using mechanical/computerized methods. Pressure come
of interest. The measure in this study was a
was measured at three sites in kPa using the FastScan
visual grading using the Seattle Wound Classifi-
system (Tekscan, Inc., South Boston, MA, USA). In
cation System that was validated by Armstrong
Germany, where the Lobmann et al.37 study was et al.39
(Table 3).
conducted, the F-Scan name belongs to another
Table 3: Outcomes and outcome measurement tools of included studies
References Outcome Outcome measurement tool
JBI Database of Systematic Reviews and Implementation Reports © 2016 THE JOANNA BRIGGS INSTITUTE 244
©2016 Joanna Briggs Institute. Penggandaan yang tidak sah dari artikel ini dilarang.
Validity of measurement tool Reiber et al.36 Primary break in
cutaneous barrier
Validated39
Colagiuri et al.10 Changes in callus
existence and grade
Observational using Seattle Wound Classification System (number)
Not validated
Lobmann et al.37 Changes in pressure
(3 regions)
Observational classification of callus (Grade 1-6) FastScan (F-Scan)40 system (kPa) Validated41
SYSTEMATIC REVIEW L. Heuch and J. Streak Gomersall
entity so the F-Scan system is marketed in Germany
(control or intervention) based on known criteria. under
the name FastScan.40 Validity for the FastS-
The lack of randomization of allocation can intro- can/F-
Scan system was determined by Pitei et al.41
duce possible confounding factors that may affect the results of the study. For example, an allocator Follow-up and
measurement intervals
may not consider that a participant is suitable for a Two
studies had a session early on in the study for
particular group and allocate based on pre-existing the
intervention group to check the fit or placement
assumptions. The method of randomization is also of the
intervention.10,37 One of these studies then
important to prevent selection bias42 and should be held
measurement sessions at 3-month intervals for 1
concealed from the allocators, for example, use of a
year,10 one study held two consecutive four weekly
computer program for random assignment of sessions
then follow-up after 4 months for a total of 6
participants to groups.43 months,36 and one measured at
2 months, 6 months
Only one study10 complied with blinding of and 1
year.37 The duration of studies was varied and
assessors to outcomes, but did not blind partici- included
trial periods from 6 months36 to a year.10,37
pants to the intervention they were allocated. The remaining studies complied poorly with blinding Methodological
quality
of both participants (Question 2) and assessors Table 4
presents the results from the critical
(Question 5).36,37 Due to the physical nature appraisal
and shows that the studies were generally
of the interventions, blinding to intervention and of poor-
to-moderate quality, with one scoring 4/
allocation in these studies was potentially difficult 10,37
and one 5/1036 and one 6/10.10
in studies where an orthotic device was used. With the
exception of the RCT,10 there was poor
While blinding may have been achieved by using
compliance to the questions involving the process of
a placebo device, it is unknown if use of a plain
randomization (Question 1) and allocation to groups
device may have produced some pressure relieving
(Question 3). The aim of randomization is to limit
effects and therefore introduced performance the extent to
which participants are placed in a group
bias42 to the findings.
Table 4: Methodological quality of included studies
Reiber et al.36 Colagiuri et al.10 Lobmann et al.37 Q1:
Assignment to treatment random NYN Q2: Subjects blinded to treatment NNN Q3: Allocators blinded to allocation
NNN Q4 All participants who started included in
YYY final analysesz Q5: Assessors of outcomes
blinded to treatment NYN Q6: Groups similar at entry YYN Q7: Group treatment similar aside from intervention
NNN
Q8: Outcomes measured in same way across groups
YYY
Q9: Reliable outcome measurement YNY Q10: Use of appropriate statistical analysis YYY Overall quality
Moderate (5/10) Moderate (6/10) Poor (4/10)
N zNo 1⁄4 withdrawals.
no; Q 1⁄4 question; Y 1⁄4 yes.
Lack of blinding of participants and data
varied.44 Bias is a function of the study design and
collectors affects the strength of the study findings
can relate to the process of selection of participants, by
introducing performance bias.42 If the partici-
allocation of participants to groups within the study, pants
are aware of which intervention they have
the treatment of the groups, how the data are been
allocated they may report experiences based
collected and measured, and how the results are on their
perceived expectation of the intervention.43
assessed.44 Similarly, with allocators and assessors, the
recording of data may be influenced by expectations of the
Findings of the review performance of a particular
intervention.43
Ulcer/break in the cutaneous barrier of the foot In the studies
assessed for this review, there were
Footwear system consisting of a manufactured no
participant withdrawals from any of the studies
shoe plus either a customized cork insole or a and so data
from all participants were considered
preformed polyurethane foam insole in the final analysis
of each of the studies
The results of the study36 investigating the effective-
(Question 4).10,36,37
ness of a footwear system consisting of a prototype Two
studies had groups that were similar at entry
shoe plus either a customized cork insole or a stand-
(Question 6).10,36 If the groups are not similar at
ard preformed PU foam insole for preventing a break
entry to the trial, direct comparisons between the
in the cutaneous barrier of the foot are presented in
groups cannot be made. Confounding factors
Table 5. A reasonably strong compliance rate of already
exist prior to the introduction of an inter-
88% was reported at weeks 4 and 8. After 3 months,
vention so results cannot be attributed to the inter-
a correlation of 0.93% between participant and vention
alone. This introduces both selection and
partner reporting of compliance was significant
performance bias,42 which seriously affects the
(P < 0.001). confidence in the findings of the study.
As may be seen prior to the introductions of both A lack
of similar treatment of groups, other than
interventions, there were no skin breaks in either the
introduction of the intervention, reduces confi-
group. After 6 months, it was found that there were dence
in the results due to performance bias.42 The
still no skin breaks reported in either group. This
assessors were measuring and recording data based
study presents some evidence, though on a very small on
different sequences of measurements, which
scale and of poor quality, that the footwear system should
not be considered comparable. The compli-
(prototype shoe, with either insole) may help ance to
Question 7 regarding similar group treat-
prevent primary ulceration in adults with diabetes. ment
other than the intervention was very poor as
It presents no evidence at all about how effective the none
of the studies reported treating the groups the
footwear system would be over a period longer than
same.10,36,37
6 months, or which insole is more effective. Also, as
Compliance regarding consistent measurements
there was no control group in this study, effective- of
outcomes across the three relevant studies was
ness of the intervention compared with no insole high
(Question 8) as groups within each of the
could not be demonstrated. studies were measured in a
consistent way.10,36,37
Two studies36,37 used validated outcome
Pressure measurement tools (Question 9), which protects
Customized rigid orthotic devices compared against
detection bias42 as validation implies that
with traditional podiatric treatment what is being
measured is what is intended to be
Table 6 presents the results for the study10 that measured.
The third study10 uses a measurement
examined effectiveness of customized rigid orthotic tool
that appears to not be validated thereby expos-
devices compared with traditional podiatric treating the
study results to detection bias.42
ment for the outcome of pressure reduction, using All studies
reported P values (Question
observational measurement focused on callus num-
10).10,36,37 The method of statistical analysis was
ber and severity. In the control group, there were a
reported in all studies10,36,37 with one study identi-
total of 32 calluses in 11 participants both before the
fying the software program used.37
intervention and after 12 months. In the intervention No
single study complied with all criteria. There
group, there were 22 calluses in nine participants are
many causes of bias, and nomenclature is
before the intervention and 20 calluses after
Table 5: Effectiveness of a footwear system comprising a prototype shoe plus customized cork insoles or
preformed polyurethane foam insoles for preventing a break in cutaneous barrier (n/N)
Polyurethane foam insole
Customized cork insole intervention Group (n/N)
intervention Group (n/N)
Before intervention After 6/12 Before intervention After 6/12 Break in
cutaneous barrier 0/24 0/24 0/24 0/24
12 months. No adverse events related to the inter-
This moderate-sized study grouped participants vention
were reported in the intervention group.
according to initial pressure measurements: plantar The
authors reported that the change/improve-
pressures >400 kPa were used as the treatment ment in
callus grade was statistically significant
group (n 1⁄4 18), with the remaining subjects forming (P
< 0.02).
the control group (n 1⁄4 63). The results of this study present
some limited
At baseline, mean pressure measurements in the
evidence that in this small group of participants,
control group were lower than those in the the use of rigid
orthotic devices may have had a
intervention groups. However, only the difference
positive effect in reducing callus grade and number.
in maximum peak pressure was statistically different
However, no firm conclusions may be drawn due to
(P 1⁄4 0.003). At 12 months, in the control group, the
small number of participants, and methodologi-
pressure measurements in all areas increased when cal
weaknesses in the study, including the use of
compared with baseline as shown in Table 7. a subjective
measurement tool which has not
This difference was statistically different in the heel been
validated.
(P 1⁄4 0.005) and the metatarsal regions (P 1⁄4 0.001). In the intervention group, measurements showed
Manufactured shoes with customized insoles
a statistically significant reduction of pressure in all
compared with conventional footwear [polyvinyl
areas up to 6 months (P < 0.05). chloride (PVC) shoes]
At 12 months, pressure in all areas in the Table 7
presents the results of the study37 that
intervention group increased when compared with
examined the effectiveness of manufactured shoes
measurements at 6 months; however, these measure- plus
insoles individualized to the participants com-
ments were comparable with the control group at pared
with conventional footwear (PVC shoe) to
baseline. At baseline, measurements between the two
decrease pressure measured in three plantar regions.
groups were significant (P 1⁄4 0.003); however, at
Table 6: Effectiveness of customized rigid orthotic devices compared with traditional podiatry treatment for
reducing callus number and severity on feet of patients with diabetes
Traditional podiatry treatment (control group n 1⁄4 11)
Rigid customized orthotic device (intervention group n 1⁄4 9)
Baseline After 12/12 Baseline After 12/12 Total number of calluses 32 32
22 20 Improved 2/32 16/20 Worsened 7/32 0/20 Same 23/32 6/20 Mean callus grade (Grade 1-6) 1.6 1.7 1.9 1.2
Table 7: Effectiveness of a manufactured shoe plus customized insole compared with conventional footwear
(PVC shoes) for reducing plantar pressure in three regions measured across different time intervals (mean Æ
SD)
Baseline
2/52 after
After 8/52
After 6/12
After 12/12 (kPa)
insole (kPa)
(kPa)
(kPa)
(kPa) Control
group (in PVC shoes)
Maximum peak pressure 367.7 Æ 157 437.4 Æ 161 Heel 263.1 Æ 127 328.3 Æ 137 Metatarsal region 339.9 Æ 171
407.6 Æ 161 Treatment group (in PVC shoes)
Maximum peak pressure 474.7 Æ 183 496.3 Æ 145 474.5 Æ 155 Heel 278.7 Æ 147 347.8 Æ 106 349.8 Æ 139
Metatarsal region 389.0 Æ 222 480.6 Æ 152 412.7 Æ 190 Treatment group (in shoes þ insole)
Maximum peak p ressure 474.7 Æ 183 290.5 Æ 106 317.9 Æ 127 324.4 Æ 127 380.8 Æ 190 Heel 278.7 Æ 147
171.9 Æ 45 177.4 Æ 52 186.1 Æ 67 266.1 Æ 97 Metatarsal region 389.0 Æ 222 290.5 Æ 106 292.5 Æ 129 303.1 Æ
139 412.6 Æ 179
12 months there was no statistical difference
>400 kPa were placed in the intervention group, between
the two groups.
which severely compromises the findings of this This study
also measured the size of pressure
study. There was no blinding of participants or reduction
in the intervention group. Measurements
allocators to treatment allocation. Outcome asses- taken
at 2 weeks following the introduction of the
sors were not blinded to treatment. Also, groups did
intervention showed a 32.6% (P < 0.001) reduction
not receive the same treatment other than in pressure. At
the 6 months measurement, a 28% (P
the intervention. 1⁄4 0.001) pressure reduction was
observed, when compared with baseline measurements. After 1 year,
Discussion however, a reduction in pressure of 13% was
The current review set out to identify the best avail-
observed when compared with baseline and was
able evidence regarding prevention of the primary not
significant.
DFU with regard to interventions used, effectiveness The
results of this study indicate that the use of
of those interventions and the relative effectiveness
manufactured shoes plus customized insole may
of different types of offloading methods. Previous have
been effective in the reduction of pressure in
SRs have investigated both prevention and treatment the
three regions tested in this group of participants
of DFUs and prevention of amputations using for up to 6
months. Also, the size of the difference in
methods of offloading including insoles,34 foot- pressure
was shown to be significant in two of the
wear,29,35 total TCC,32 surgical intervention35 and
three regions. There is no evidence to support the use
complex versus single interventions,33 among others. of
manufactured shoes plus insole for reduction in
However, this is the first review investigating the pressure
for a period longer than 6 months.
effectiveness of simple offloading methods specifi- These
results should be viewed with caution due
cally for primary ulcer prevention in those to
methodological weaknesses. There was no
with diabetes. randomization of allocation to treatment
groups;
Following an extensive search, only three studies
allocation was based on initial pressure measure-
fit the inclusion criteria. Overall, the studies ments: those
with plantar pressure measurements
examined four interventions and two comparators.
Following critical appraisal using the JBI Critical
The SRs of RCTs by Spencer32 in 2000 found that
Appraisal Checklist for Randomized Control/
while there were some pressure-relieving benefits of
Pseudo-randomized Trial (Appendix II), one study
orthoses, no evidence was available regarding was
classified as poor37 quality and two as moder-
particular devices, a conclusion that is supported
ate.10,36 Methodological weaknesses were noted in
by the findings of this SR. Spencer also suggested each of
the studies.
that the use of running shoes to relieve pressure The JBI
Levels of Evidence (Appendix VI), which
should be evaluated further. classifies studies based on
study design, rates each of
Paton et al.34 found limited evidence to support the
three studies at level E2 on the Effectiveness scale
using insoles to prevent ulcer formation, but where E1 is
high and E4 is low.
reported that further investigation regarding their There is
limited primary research in the area of
use in conjunction with prevention strategies for primary
prevention of DFUs, and it was disappoint-
those at risk of developing a DFU was warranted. ing that
no study was found for the primary outcome
No recommendations were made with regard to of
interest for this review; prevention of the develop-
specifics related to different types of insoles. Findings
ment of a primary DFU. The only study with out-
of this SR support the recommendations by Paton for
comes related to ulcer formation was of moderate
future research comparing a range of insoles as well
quality with methodological weaknesses. This
as their different modes of action, the effectiveness of
study36 provided limited and weak evidence that
prefabricated versus customized insoles and also the use
of a footwear system consisting of prototype
longevity of devices. shoe plus an insole (preformed PU
or customized
The SR of SRs and RCTs by Hunt22concluded that
cork) might prevent skin breakage leading to devel-
there was limited evidence regarding the use of foot-
opment of an ulcer but provided no evidence to
wear specifically to reduce pressure and insufficient
determine which device is more effective or the
evidence to support wearing of therapeutic footwear
effectiveness for a period longer than 6 months.
to prevent the development of DFUs. Further research
Without a control group for comparison, there is
into the use of footwear, both therapeutic and stock, no
evidence regarding effectiveness compared with
to reduce pressure and prevent DFUs is also recom- no
device.
mended as a result of the findings of this SR. The two
studies identified which addressed the
The search process for this review identified a
secondary outcome of interest, reduction of pres-
small number of studies (the most recent was pub- sure,
also had methodological weaknesses and were
lished in 2001), including one study that was not of
poor37 or moderate10 quality. One of these stud-
previously identified in existing SRs. Disappoint- ies10
provided weak evidence that customized rigid
ingly, the range of interventions in the included orthotic
devices may reduce the number and grade of
studies was limited. The lack of any study on the callus
over a period of a year; however, no evidence
effectiveness of using padding in any form (simple of
validation of the measurement tool could
foam, silicon and felt) to prevent DFUs in adults with be
found.
no history of DFUs is particularly noteworthy. This The final
study37 demonstrated that there is some
is noteworthy because many foot care professionals
limited evidence that manufactured shoes plus cus-
utilize this method, which is affordable and rela- tomized
insoles might be useful in reducing plantar
tively easy to use. pressures in three plantar regions over
a period not
The low number of studies and lack of recent studies
longer than 6 months. Methodological weaknesses
identified by this review indicates a large gap in the in
this study severely compromised the findings of
evidence base on effectiveness of offloading measures
this study, in particular, the allocation of partici-
for preventing primary DFUs in patients with diabetes.
pants to groups based on clinical assessment, and the
Others have identified this knowledge gap, for difference
in treatment between the two groups.
example, Bus et al.29 in a SR published in 2008. None of the
studies reported consideration of participants' comorbidities, medication not related
Limitations of the review to diabetes, activity levels,
fitness levels and other
Restricting search limits to studies published only
lifestyle-related possibilities that could introduce
in English may have excluded potentially relevant
confounding factors not considered in the results.
studies published in languages other than English.
It is acknowledged that the initial search in
those studies that used participants with no history
November 2013 could be considered out of date.
of DFU. New research may have been published since
which
The range of outcomes included in the review was
could contribute to the evidence. While a duplicate
narrow and included only signs of an ulcer and search by
the primary author (LH) of PubMed and
pressure reduction. Other outcomes, not included
CINAHL databases from November 16, 2013 to
in this review, which are important to measure to October
5, 2015 did not produce any further studies,
inform practice, included compliance, cost/afford- a more
rigorous search of the other databases could
ability, patient preference, comfort and pain. The
potentially provide more recent studies that may be
scope was kept purposefully narrow to examine
considered relevant; however, time restraints did not
prevention from a clinical perspective. allow for this.
The data extraction was conducted by only one As
previously outlined, the decision to deviate
reviewer, potentially allowing for errors in the tran- from
the protocol and include only studies that
scription of the data. No checking system was in included
participants with no current or previous
place to determine if data extracted was recorded DFUs
was based on the observation during the
correctly. course of this review that SRs that considered
treatment of current and prevention of subsequent DFUs already existed. No existing SR that related specifically
to the use of offloading for primary DFU prevention was identified.
Also, studies which used mixed groups of participants, that is, with and without a history of DFUs, but did not
report the findings separately, were excluded. The relatively large number of studies (26 in total) in these categories
combined with unsuccessful early attempts to obtain information from some authors influenced this decision. Time
and resources permitting, it would have been productive to have written to authors of these studies to clarify details
and gain more detailed information for possible inclusion in this review. It is recognized that some potentially
relevant studies may have been missed or excluded, which would have contributed to the findings of this review;
however, the objective of this review was to identify evidence specifically related to primary
Conclusion The current review set out to address the question of effectiveness of offloading interventions to prevent
primary foot ulcers in adults with diabetes. Only three studies that fit the criteria for this review were identified and
subsequently analyzed. Across those three studies, a total of four interventions and two comparators were examined
across a range of two outcomes: primary break in the cutaneous barrier and pressure (determined by callus number
and grade), and measurable changes in plantar pressure. There were no high-quality studies identified.
As reported in the ''Results'' section of this review, each of the three studies provided some limited evidence on
the effectiveness of the interventions used, but limitations within each of the studies suggest that these results
should be viewed with caution.
prevention.
A total of seven studies were excluded due to
Implications for practice insufficient data in full text
(three) or inability to
Foot care professionals should advise patients that
retrieve the study in full text (four). It is also recog-
there is very limited and poor-quality evidence nized that
these studies may have provided valuable
to support the use of the following offloading evidence,
and their exclusion may have influenced
interventions: footwear system with prototype the
findings of this review.
shoe plus either a standard preformed PU insole It is also
acknowledged that studies that included
or customized cork insole' customized rigid participants
with healed DFUs may provide some
orthotic devices, and manufactured shoes with useful
evidence that could be used in relation to
customized insole for the prevention of primary primary
prevention. However, in the absence of
DFUs. This evidence should be used with caution
evidence regarding an ideal interval between healing
as the evidence base is weak and there is no of a DFU and
being at no greater risk than those
evidence regarding which of these interventions without
any prior ulceration, we decided to use only
is the most effective.
Implications for research

Cowin and Rebecca Daebeler for their roles as The gaps
in the evidence base and methodological
secondary supervisors. weaknesses in the included studies
offer directions for future research.
There is a need for further randomized controlled trials, comprising large groups of participants, using validated
measurement tools over extended periods
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Appendix I: Search strategy for PubMed and CINAHL databases

PubMed search 16 November 2013
Search Query No. 1 (Offloading[tw] OR Off loading[tw] OR Off-weighting[tw] OR Off weighting[tw] OR
Pad[tw] OR Pads[tw] OR Padding[tw] OR CushionÃ[tw] OR Load redistribution[tw] OR Pressure relief[tw] OR
Pressure relieving[tw] OR Pressure reduction[tw] OR Pressure/ ae[mh:noexp] OR FootÃ[tw] OR Footwear[tw] OR
Foot wear[tw] OR ShoeÃ[tw] OR shoe[mh] OR InsoleÃ[tw] OR CustomÃ[tw] OR PrefabÃ[tw] OR OrthoticÃ[tw]
OR Ortho- sesÃ[tw] OR Orthotic deviceÃ[tw] OR Rocker soleÃ[tw] OR Rocker-soleÃ[tw] OR Rock- erÃ[tw]) No.
2 (Diabetic foot[mh] OR ((Diabetes Complication[mh:noexp] OR Diabetes Related Complica-
tions[tw] OR Diabetes-Related ComplicationÃ[tw] OR Diabetic ComplicationÃ[tw] OR Diabetes
complicationÃ[tw] OR Diabetes mellitus complicationÃ[tw] OR Complications of Diabetes Mellitus[tw] OR
Diabetes Mellitus ComplicationÃ[tw]) No. 3 (f oot[tw] OR feet[tw]) OR Diabetic Foot[tw] OR Diabetic Feet[tw]
OR Feet, Diabetic[tw]
OR Foot Ulcer, Diabetic[tw] OR (foot[tw] or feet) No. 4 ulcerÃ[tw] AND diabetÃ[tw] No. 5 (Prevention
and control[sh] OR preventÃ[tw] OR Prophylaxis[tw] OR Prophylactic[tw] OR
preventive therapy[tw] OR preventive measures[tw] OR prevention[tw] OR controlÃ[tw] OR interventionÃ[tw] OR
interveneÃ[tw] OR pressure reduction[tw]) No. 6 No. 1 AND No. 2 AND No. 3 AND No. 4 AND No. 5 Limits
Case Reports; Clinical Trial; Comparative Study; Evaluation Studies; Multicenter Study;
Randomized Controlled Trial; Publication date from 1950/01/01 to 2013/11/16; Manusia; English; Adult: 19þ years;
Adolescent: 13-18 years; Field: Text Word
CINAHL search 16 November 2013
Search Query No. 1 prevention diabetic foot ulcers No. 2 (MH ''Athletic Shoes'') OR (MH ''Shoes'') OR (MH
''Orthopedic Footwear'') OR (MH ''Orthoses'') OR (MH ''Weight-Bearing'') OR ''rocker sole'' OR ''relief of pressure''
OR ''insole'' OR ''padding'' OR ''offloading'' No. 3 (MH ''Diabetes Mellitus, Type 2'') OR (MH ''Diabetes Mellitus,
Type 1'') OR ''diabetes'') No. 4 (MH ''Young Adult'') OR (MH ''Adult'') OR (MH ''Middle Age'') OR (MH ''Aged'')
No. 5 (MH ''Diabetic Foot'') OR (MH ''Foot Ulcer'') OR (MH ''Foot Care'') OR (MH ''Foot
Injuries'') No. 6 (MH ''Pathologic Processes'') OR (MH ''Ulcer'') OR (MH ''Nerve Degeneration'') No. 7
(MH ''Diabetic Neuropathies'') OR (MH ''Diabetes Mellitus'') OR (MH ''Diabetes Mellitus,
Type 2'') No. 8 No. 1 AND No. 2 AND No. 3 AND No. 4 AND No. 5 AND No. 6 AND No. 7 Limits
English language: 19500101-20131116
JBI Database of Systematic Reviews and Implementation Reports © 2016 THE JOANNA BRIGGS INSTITU TE 253
Appendix II: Appraisal instruments MAStARI appraisal instrument
Appendix III: Data extraction instruments MAStARI data extraction instrument
Appendix IV: Excluded studies following full paper retrieval and reasons for exclusion
Actis RL, Ventura LB, Lott DJ, Smith KE, Commean PK, Hastings MK, et al. Multi-plug insole design to reduce
peak plantar pressure on the diabetic foot during walking. Med Biol Eng Comput 2008;46(4):363-71. Reason for
exclusion: this study did not fulfil the population requirement relating to this review: it was unclear if the
participants had a history of previous diabetic foot ulcers.
Albert SF, Chen WY. Rigid foot orthoses in the treatment of the neuropathic diabetic foot. Low Extrem
1996;3(2):97-105. Reason for exclusion: this study did not fulfil the population requirement relating to this review:
some/all participants had a history of previous diabetic foot ulcers.
Albert S, Rinoie C. Effect of custom orthotics on plantar pressure distribution in the pronated diabetic foot. J Foot
Ankle Surg 1994;33(6):598-604. Reason for exclusion: this study did not fulfil the population requirement relating
to this review: some/all participants had a history of previous diabetic foot ulcers.
Bucki M, Vuillerme N, Cannard F, Diot B, Becquet G, Payan Y. The TexiSense «Smart Sock» – a device for a daily
prevention of pressure ulcers in the diabetic foot. Ann Phys Rehabil Med 2011;54(S1):e159. Reason for exclusion:
this study did not fulfil the population requirement relating to this review.
Bus SA, Ulbrecht JS, Cavanagh PR. Pressure relief and load redistribution by custom-made insoles in diabetic
patients with neuropathy and foot deformity. Clin Biomech 2004;19(6):629-38. Reason for exclusion: this study did
not fulfil the population requirement relating to this review: some/all participants had a history of previous diabetic
foot ulcers.
Bus SA, van Deursen RWM, Kanade RV, Wissink M, Manning EA, van Baal JG, et al. Plantar pressure relief in the
diabetic foot using forefoot offloading shoes. Gait Posture 2009;29(4):618-22. Reason for exclusion: this study did
not fulfil the population requirement relating to this review: it was unclear if the participants had a history of
previous diabetic foot ulcers.
Bus SA, Haspels R, Busch-Westbroek TE. Evaluation and optimization of therapeutic footwear for neuropathic
diabetic foot patients using in-shoe plantar pressure analysis. Diabetes Care 2011;34(7):1595-1600. Reason for
exclusion: this study did not fulfil the population requirement relating to this review: some/all participants had a
history of previous diabetic foot ulcers.
Charanya GK, Patil KM, Narayanamurthy VB, Parivalavan R, Visvanathan V. Effect of foot sole hardness,
thickness and footwear on foot pressure distribution parameters in diabetic neuropathy. Proc Inst Mech Eng
Cumming A, Bayliff T. Plantar pressure: comparing two poron insoles. Diabetic Foot J 2004;14(2):86-9. Reason for
exclusion: this study did not fulfil the population requirement relating to this review: it was unclear if the
Curryer M, Lemaire ED. Effectiveness of various materials in reducing plantar shear forces. A pilot study. J Am
Podiatr Med Assoc 2000;90(7):346-53. Reason for exclusion: this study did not fulfil the population requirement
relating to this review: it was unclear if the participants had a history of previous diabetic foot ulcers.
Dabiri F, Vahdatpour A, Noshadi H, Hagopian H, Sarrafzadeh M. Electronic orthotics shoe: preventing ulceration in
diabetic patients. Paper presented at: The 30th Annual International Conference of the IEEE EMBS; August 20-24,
2008; Vancouver, Kanada. Reason for exclusion: this study did not fulfil the population requirement relating to this
review.
do Carmo Dos Reis M, Soares FA, da Rocha AF, Carvalho JLA, Rodrigues SSFR. Insole with pressure control and
tissue neoformation induction systems for diabetic foot. Paper presented at: The 32nd Annual International
Conference of the IEEE EMBS; August 31-September 4, 2010; Buenos Aires, Argentina. Reason for exclusion: this
study did not fulfil the population requirement relating to this review.
Donaghue VM, Sarnow MR, Giurini JM, Chrzan JS, Habershaw GM, Veves A. Longitudinal in-shoe foot pressure
relief achieved by specially designed footwear in high risk diabetic patients. Diabetes Res Clin Pract 1996;31(1-
3):109-14. Reason for exclusion: this study did not fulfil the population requirement relating to this review: some/all
Duckworth T, Boulton AJM, Betts RP, Franks CI, Ward JD. Plantar pressure measurements and the prevention of
ulceration in the diabetic foot. J Bone Joint Surg Br 1985;67(1):79-85. Reason for exclusion: this study did not fulfil
the intervention requirements relating to this review.
Duffin AC, Kidd R, Chan A, Donaghue KC. High plantar pressure and callus in diabetic adolescents. Incidence and
treatment. J Am Podiatr Med Assoc 2003;93(3):214-20. Reason for exclusion: this study did not fulfil the population
requirement relating to this review.
Garrow AP, van Schie CHM, Boulton AJM. Efficacy of multilayered hosiery in reducing in-shoe plantar foot
pressure in high-risk patients with diabetes. Diabetes Care 2005;28(8):2001-6. Reason for exclusion: this study did
not fulfil the population requirement relating to this review: it was unclear if the participants had a history of
Giacalone VF, Armstrong DG, Ashry HR, Lavery DC, Harkless LB, Lavery LA. A quantitative assessment of
healing sandals and postoperative shoes in offloading the neuropathic diabetic foot. J Foot Ankle Surg
1997;36(1):28. Reason for exclusion: this study did not fulfil the intervention requirement relating to this review.
Guldemond NA, Leffers P, Schaper NC, Sanders AP, Nieman F, Willems P, et al. The effects of insole
configurations on forefoot plantar pressure and walking convenience in diabetic patients with neuropathic feet. Clin
Biomech 2007;22(1):81-7. Reason for exclusion: this study did not fulfil the population requirement relating to this
review: it was unclear if the participants had a history of previous diabetic foot ulcers.
Hacker H. Evaluating the effects of foot orthotics on plantar pressures in the diabetic population. [Internet]. 2005
[cited 2013 Nov 20]. Reason for exclusion: unable to retrieve this paper in full text.
Kastenbauer T, Sokol G, Auinger M, Irsigler K. Running shoes for relief of plantar pressure in diabetic patients.
Diabet Med 1998;15(6):518-22. Reason for exclusion: this study did not fulfil the population requirement relating to
this review: some/all participants had a history of previous diabetic foot ulcers.
Kato H, Takada T, Kawamura T, Hotta N, Torii S. The reduction and redistribution of plantar pressures using foot
orthoses in diabetic patients. Diabetes Res Clin Pract 1996;31:115-8. Reason for exclusion: this study did not fulfil
the population requirement relating to this review: some/all participants had a history of previous diabetic foot
ulcers.
Kavros SJ, Van Straaten MG, Coleman Wood KA, Kaufman KR. Forefoot plantar pressure reduction of off- the-
shelf rocker bottom provisional footwear. Clin Biomech. 2011;26(7):778-82.
Reason for exclusion: this study did not fulfil the population requirement relating to this review: some/all
Lavery LA, Peters EJG, Armstrong DG. What are the most effective interventions in preventing diabetic foot ulcers?
Int Wound J 2008;5(3):425-33. Reason for exclusion: this study did not fulfil the population requirement relating to
this review: some/all participants had a history of previous diabetic foot ulcers.
Lavery LA, LaFontaine J, Higgins KR, Lanctot DR, Constaninides G. Shear-reducing insoles to prevent foot
ulceration in high-risk diabetic patients. Adv Skin Wound Care 2012;25(11):519-24. Reason for exclusion: this
study did not fulfil the population requirement relating to this review: some/all participants had a history of previous
diabetic foot ulcers.
Levin ME. Prevention and treatment of diabetic foot wounds. J Wound Ostomy Continence Nurs 1998;25(3):129-
46. Reason for exclusion: this study did not fulfil the population requirement relating to this review: some/all
Litzelman DK, Marriott DJ, Vinicor F. The role of footwear in the prevention of foot lesions in patients with
NIDDM: conventional wisdom or evidence-based practice? Diabetes Care 1997;20(2):156-62. Reason for exclusion:
this study did not fulfil the population requirement relating to this review: Some/all participants had a history of
Lord M, Hosein R. Pressure redistribution by molded inserts in diabetic footwear: a pilot study. J Rehabil Res Dev
Mueller MJ, Zou D, Bohnert KL, Tuttle LJ, Sinacore DR. Plantar stresses on the neuropathic foot during barefoot
walking. Phys Ther 2008;88(11):1375-84. Reason for exclusion: this study did not fulfil the population requirement
relating to this review: some/all participants had a history of previous diabetic foot ulcers.
Murray HJ, Veves A, Young MJ, Richie DH, Boulton AJM. Role of experimental socks in the care of the high-risk
diabetic foot. Diabetes Care 1993;16(8):1190-2. Reason for exclusion: this study did not fulfil the population
requirement relating to this review: some/all participants had a history of previous diabetic foot ulcers.
Owings TM, Woerner JL, Frampton JD, Cavanagh PB, Botek G. Custom therapeutic insoles based on both foot
shape and plantar pressure measurement provide enhanced pressure relief. Diabetes Care 2008;31(5):839-44.
Reason for exclusion: this study did not fulfil the population requirement relating to this review: it was unclear if the
Paton J, Stenhouse E, Jones R, Bruce G. Custom-made total contact insoles and prefabricated functional diabetic
insoles: A case report. Diabetic Foot J 2007;10(3):138-43. Reason for exclusion: this study did not fulfil the
population requirement relating to this review: some/all participants had a history of previous diabetic foot ulcers.
Paton JS, Stenhouse EA, Bruce G, Zahra D, Jones RB. A comparison of customised and prefabricated insoles to
reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial. J Foot
Ankle Res 2012;5(1):31. Reason for exclusion: this study did not fulfil the population requirement relating to this
Perry JE, Ulbrecht JS, Derr JA, Cavanagh PR. The use of running shoes to reduce plantar pressures in patients who
have diabetes. J Bone Joint Surg Am 1995;77(12):1819-28.
Reason for exclusion: this study did not fulfil the population requirement relating to this review: some participants
did not have diabetes.
Pitei DL, Foster A, Edmonds M. The effect of regular callus removal on foot pressures. J Foot Ankle Surg
1999;38(4):251-5. Reason for exclusion: this study did not fulfil the intervention requirements relating to this
review.
Praet SFE, Louwerens JWK. The influence of shoe design on plantar pressures in neuropathic feet. Diabetes Care
it was unclear if the participants had a history of previous diabetic foot ulcers.
Raspovic A, Landorf KB, Gazarek J, Stark M. Reduction of peak plantar pressure in people with diabetes- related
peripheral neuropathy: an evaluation of the DH Pressure Relief ShoeTM. J Foot Ankle Res 2012;5(25). Reason for
exclusion: this study did not fulfil the population requirement relating to this review: some/all participants had a
history of previous diabetic foot ulcers.
Resch S, Apelqvist J, Stenstro ̈m A, A
̊
stro ̈m I. Dynamic plantar pressure measurement in 49 patients with diabetic
neuropathy with or without foot ulcers. Foot Ankle Surg 1997;3(4):165-74. Reason for exclusion: this study did not
fulfil the intervention requirements relating to this review.
Rizzo L, Tedeschi A, Fallani E, Coppelli A, Vallini V, Iacopi E, et al. Custom-made orthesis and shoes in a
structured follow-up program reduces the incidence of neuropathic ulcers in high-risk diabetic foot patients. Int J
Low Extrem Wounds 2012;11(1):59-64. Reason for exclusion: this study did not fulfil the population requirement
relating to this review: some/all participants had a history of previous diabetic foot ulcers.
Rong M, Gu Y, Ruan G. A pilot study on footwear biomechanical effect to diabetic patients. Paper presented at: The
2011 International Conference on Biotechnology, Chemical and Materials Engineering; December 28-29, 2011;
Kunming, China. Reason for exclusion: insufficient data available from full text.
Scire V, Leporati E, Teobaldi I, Nobili LA, Rizzo L, Piaggesu A. Effectiveness and safety of using Podikon digital
silicone padding in the primary prevention of neuropathic lesions in the forefoot of diabetic patients. J Am Podiatr
Med Assoc 2009:99(1):28-34. Reason for exclusion: this study did not fulfil the population requirement relating to
this review: it was unclear if the participants had a history of previous diabetic foot ulcers.
Slater RA, Hershkowitz I, Ramot Y, Buchs A, Rapoport MJ. Reduction of digital plantar pressure by debridement
and silicone orthosis. Diabetes Res Clin Pract 2006;74(3):263-6. Reason for exclusion: this study did not fulfil the
Soulier SM. The use of running shoes in the prevention of plantar diabetic ulcers. J Am Podiatr Med Assoc
1986;76(7):395-400. Reason for exclusion: this study did not fulfil the population requirement relating to this
Soulier SM, Godsey C, Asay ED, Perrotta DM. The prevention of plantar ulceration in the diabetic foot through the
use of running shoes. Diabetes Educ 1987;13(2):130-2. Reason for exclusion: this study did not fulfil the population
requirement relating to this review: it was unclear if the participants had a history of previous diabetic foot ulcers.
Tang U. Effectiveness of insoles provided to patients with diabetes. A Longitudinal Randomized Controlled Study
in Gothenburg [Internet]. 2012. Available from: http://clinicaltrials.gov/ct2/show/study/
NCT01663519?term=ulcer&intr=orthotic&rank=2 [cited 2013 Nov 20]. Reason for exclusion: unable to retrieve this
paper in full text.
Tong JW, Acharya UR, Chua KC, Tan PH. In-shoe plantar pressure distribution in nonneuropathic type 2 diabetic
patients in Singapore. J Am Podiatr Med Assoc 2011;101(6):509-16. Reason for exclusion: this study did not fulfil
the intervention requirements relating to this review.
Tsung BYS, Zhang M, Mak AFT, Wong MWN. Effectiveness of insoles on plantar pressure redistribution. J
Rehabil Res Dev 2004;41(6A):767-74. Reason for exclusion: this study did not fulfil the population requirement
relating to this review: it was unclear if the participants had a history of previous diabetic foot ulcers.
Veitenhansl M, Hierl FX, Landgraf R. Diabetic foot syndrome: a prospective randomised study with various shoe
models to prevent ulceration. Diabetic Foot Study Group of the EASD. 2001;27. Reason for exclusion: unable to
retrieve this paper in full text.
Veitenhansl M, Hierl FX, Landgraf R. Pressure reduction through various premanufactured shoe models with
insoles in diabetic foot syndrome to prevent ulceration: a prospective randomised study. Diabetologia 2003;46(2
Suppl):A4-5. Reason for exclusion: this study did not fulfil the population requirement relating to this review:
Veitenhansl M, Stegner K, Hierl FX, Dieterle C, Feldmeier H, Gutt B, et al. Special pre-manufactured footwear with
insoles can prevent ulceration in diabetic patients with diabetic foot syndrome by pressure reduction. A prospective
randomised study. Diabetologica 2004;47(1):A3. Reason for exclusion: unable to retrieve this paper in full text.
Veves A, Masson EA, Fernando DJS, Boulton AJM. Use of experimental padded hosiery to reduce abnormal foot
pressures in diabetic neuropathy. Diabetes Care 1989;12(9):653-5. Reason for exclusion: this study did not fulfil the
Veves A, Masson EA, Fernando DJS, Boulton AJM. Studies of experimental hosiery in diabetic neuropathic patients
with high foot pressures. Diabetic Med 1990;7(4):324-6. Reason for exclusion: this study did not fulfil the
Viswanathan V, Madhavan S, Gnanasundaram S, Gopalakrishna G, Das BN, et al. Effectiveness of different types
of footwear insoles for the diabetic neuropathic foot. Diabetes Care 2004;2(27):474-7. Reason for exclusion: this
study did not fulfil the population requirement relating to this review: some/all participants had a history of previous
diabetic foot ulcers.
Zequera M, Stephan S, Paul J. Effectiveness of moulded insoles in reducing plantar pressure in diabetic patients.
Proceedings of the 29th Annual International Conference of the IEEE EMBS; August 23-26, 2007; Lyon, Prancis.
Reason for exclusion: insufficient data available from full text.
Zequera ML, Solomonidis S. Performance of insole in reducing plantar pressure on diabetic patients in the early
stage of the disease. Paper presented at: The 32nd Annual International Conference of the IEEE EMBS; August 31-
September 4, 2010; Buenos Aires, Argentina. Reason for exclusion: insufficient data available from full text.
Appendix V: Characteristics of included studies

References Design Setting Participants
Intervention(s) and comparators
Outcome and outcome measurement Reiber
Prospective
VA Puget
Participants:
Comparator
Outcome/s et al.36
non-
Sound Health
24 (all M)
None
(1) Primary break in randomized
Care System,
Neuropathy:
Two interventions
cutaneous barrier crossover
Seattle, USA
14.4 (60%) in
(1) Footwear system
Direct observation: study
at least one
consisting of a
Seattle Wound (6 months)
foot
prototype shoeÃ þ
Classification Age: mean 66
standard preformed
System yrs
polyurethane foam
(2) Other adverse DM duration:
insole
events: blisters, 44% had >10
(2) Footwear system
callus, ID fungal yrs
consisting of a
infection, redness on BMI: 28.6 Æ
prototype shoeÃ þ
dorsum of toes 3.9
customized cork insole
Direct observation Weight: not
ÃPrototype shoes:
(3) Compliance reported
leather upper,
Interviewer HbA1c: not
depth-inlay, blucher
administered activity reported
style, front laced shoe
log and question with extra forefoot
(4) Satisfaction volume and a urethane
Questions re rocker sole
appearance, Shoe size US10-101/2
comfort, stability Fit assessed after 1
and weight week Participants wore intervention 1 or 2 or 4/52 each then choice of one
intervention for 4/12 for total of 6 months
(Continued)
Outcome and outcome measurement Colagiuri
Randomized et al.10
control trial (1 year)
Diabetes Centre, Prince of Wales Hospital, Randwick, NSW, Australia
Participants: 20 (5M and 15F) Control group: 8 Intervention group: 11 Neuropathy: 8 Age: Control: 69 Æ 6 yrs
Intervention: 63 Æ 10 yrs DM duration: 8.4 Æ 7.5 yrs (all) BMI: not reported Weight: 75 Æ 10 kg (all) HbA1c: not
reported Callus: grade 1-3 (all)
Comparator Traditional treatment by podiatrist including paring of hyperkeratotic skin, moisturizers and
hypoallergenic padding Comparator group treated by podiatrist at 3/12 intervals for 1 year Intervention Customized
rigid foot orthotic devices manufactured from Rohadur Intervention group received no traditional treatment for
calluses and wore custom made orthotic devices for at least 7/24 per day. Reviewed at 1-3/52 to check fit then 3/12
intervals for 1 year Measurements at baseline and 1 year
Outcome Plantar callus, existing and grade Observational measurements via photographs Graded as 1-6 with; Grade
1: distinct area with minimal thickening of keratin layer Grade 2: moderate thickening of keratin layer Grade 3:
marked thickening of keratin layer Grade 4: callus þ hematoma Grade 5: callus þ ulcer Grade 6: callus þ infected
ulcer
(Continued)
Outcome and outcome measurement Lobmann
Prospective et al.37
before and after study (1 year)
Dept of Endocrin- ology & Metabolism & Dept of Orthopaedic Surgery, University Medical School of Magdeburg,
Germany
Participants: 81 (31M and 50F) Control group: 18 Intervention group: 63 (Intervention group selected based on
>400 kPa plantar pressure at baseline) Neuropathy: 81 Age: Control: 66 Æ 10 yrs Intervention: 63 Æ 9 yrs DM
duration: 13.05 Æ 6.3 (all) BMI: 26.45 Æ 3.7 (all) Weight: not reported HbA1c (at baseline): Control group: 7.3 Æ
1.9% Intervention group: 6.9 Æ 1.3%
Comparator Conventional footwear (PVC shoe) Comparator group measure at 6/12 and 12/12 with only 12/12
measurements reported Intervention Manufactured shoes to Tovey's model þ customized insole using combination
of ethylene-vinyl-acetate, polythene foam, elastomer and silicone to an overall insole thickness of 14 mm Existing
HK removed prior to measurement Average wear time 29 Æ 15 h/week (daily protocol completed by participants)
Intervention group measurements taken at 2/52, 8/52, 6/12 and 12/12
Outcome Pressure measured in 3 regions: (1) Total foot area (maximum plantar pressure) (2) Heel region (3) 1st,
2nd and 3rd metatarsal heads (metatarsal region) FastScan (F-Scan) system (kPa) Measurements: after third step
Appendix VI: JBI Levels of Evidence

Levels of
Feasibility
Meaningfulness
Effectiveness Evidence
F (1–4)
M (1–4)
E (1–4) Economic evidence 1
Metasynthesis
of research with unequivocal synthesized findings
Appropriateness A (1–4)
Metasynthesis (with homogeneity) of evaluation of important alterna- tive interventions comparing all clinically
relevant outcomes against appropriate cost measurement, and including a clinically sensible sensitivity analysis 2
Metasynthesis
of research with credible synthesized findings
Metasynthesis
Metasynthesis
Meta-analysis of research with
of research with
(with homogen- unequivocal syn-
unequivocal syn-
eity) of exper- thesized findings
thesized findings
imental studies (eg RCT with concealed randomisation) OR one or more large experimental studies with narrow
confidence intervals
Evaluation of important alterna- tive interventions comparing all clinically relevant outcomes against appropriate
cost measurement, and including a clinically sensible sensitivity analysis 3 a. Metasynth-
esis of text/ opinion with credible synthesized findings b. One or more single research studies of high quality
Metasynthesis
Metasynthesis
One or more of research with
of research with
smaller RCTs credible synthes-
credible synthes-
with wider confi- ized findings
ized findings
dence intervals OR Quasi-experimental studies (without randomisation)
a. Metasynthesis
a. Metasynthesis
a. Cohort study
Evaluations of of text/opinion
of text/opinion
(with control
important alterna- with credible
with credible
group)
tive interventions synthesized
synthesized find-
b. Case-
comparing a limited findings
ings
controlled
number of b. One or more
b. One or more
c. Observational
appropriate cost single research
single research
study (without
measurement, studies of high
studies of high
control group)
without a clinically quality
quality
sensible sensitivity analysis 4 Expert opinion Expert opinion Expert opinion Expert opinion,
or physiology bench research, or consensus
Expert opinion, or based on economic theory

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Tabel 2: Peserta dalam studi termasuk

Implications for research

2009;103(2):137–49. prevention of a primary DFU.

diabetes.WHO; 2012; Available from:

S84–92. Gathering of information regarding current

2000;12(4):82–7. enable researchers to consider

Appendix I: Search strategy for PubMed and CINAHL databases

Appendix V: Characteristics of included studies

Appendix VI: JBI Levels of Evidence

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