New Clinical Guidelines Off-Load and Help Heal Diabetic Foot Ulcers

NEW CLINICAL GUIDELINES TO OFF-LOAD & HELP
HEAL DIABETIC FOOT ULCERS:

ACTIONABLE EVIDENCE TO IMPROVE OUTCOMES
David G. Armstrong, DPM, MD, PhD

Professor of Surgery and Director
Southern Arizona Limb Salvage Alliance (SALSA)
University of Arizona College of Medicine
Robert Snyder, DPM, MSc

Professor and Director, Clinical Research
Barry University School of Podiatric Medicine
Past President, Association for the Advancement of Wound Care
Andrew J. Applewhite, MD
Medical Director, Comprehensive Wound Center of Baylor
University Medical Center
This educational event is supported by Derma Sciences Inc.

AGENDA
1. David Armstrong, DPM, MD, PhD

• Are DFUs worse and more costly than cancer?
• Stairway to amputation
2. Rob Snyder, DPM, MSc

• New consensus guidelines: DFU management through
optimal off-loading
• Evidence-based off-loading selection
3. Andrew J. Applewhite, MD
• Off-loading in practice
• Practical Implementation in a clinic
1. David Armstrong, DPM, MD, PhD

• Are DFUs worse and more costly than
cancer?
• Stairway to amputation
DIABETES, A GROWING THREAT
In 2011, 26 million 15% of patients

Americans had with diabetes are
diabetes (8.3% of at risk of developing
the US population)1 a foot ulcer (DFU)2
45% 5-year mortality 85% of lower extremity

rate post-LEA among amputations (LEAs)
diabetic patients4 in diabetic patients
are preceded by a
foot ulcer3
1. Centers for Disease Control. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.

2. National Diabetes Data Group: Diabetes in America, Vol. 2. Bethesda, MD, National Institutes of Health 1995 (NIH publ. no. 95-1468)
3. Incidence of diabetic foot ulcer and lower extremity amputation among Medicare beneficiaries, 2006 to 2008, www.ahrq.gov.
4. Centers for Disease Control http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.
5-YEAR MORTALITY VS. CANCER
100 97
86
80
64
Percent
60 55
45 47 48
40
18 18
20
8
0
Armstrong DG, Wrobel J, Robbins JM. Are diabetes-related wounds and amputations worse than cancer? Int Wound J. 2007;4(4):286–7.
COST VS. CANCER
HEALTH CARE COSTS
• Nearly 80,000 LEAs are performed on diabetics

each year1
• Two-year costs associated with initial

hospitalization, rehospitalizations, post-acute care
and prosthesis-related costs were $91,1062
• The projected lifetime health care cost for the

patients who had undergone amputation $509,2752
1. Incidence of diabetic foot ulcer and lower extremity amputation among Medicare beneficiaries, 2006 to 2008, www.ahrq.gov.
2. MacKenzie EJ1, et al. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. J Bone Joint Surg Am. 2007
Aug;89(8):1685-92.
STAIRWAY TO AMPUTATION
THREE QUESTIONS
1. What am I going to take off this wound that might

help it heal?
2. What can I put on this wound that might help it

heal faster, easier and better?
3. How can I prevent (severe) recurrence?

OFF-LOADING EVIDENCE-BASED SOLUTIONS
Sackett DL, Straus SE, Richardson WS, et al. Evidence-based medicine: how to practice and teach EBM. 2nd
ed. Edinburgh: Churchill Livingstone, 2000.
2. Rob Snyder, DPM, MSc

• New consensus guidelines: DFU
management through optimal off-
loading
• Evidence-based off-loading section
THE MANAGEMENT OF DIABETIC
FOOT ULCERS THROUGH OPTIMAL
OFF-LOADING
Building Consensus Guidelines and Practical
Recommendations to Improve Outcomes
Journal of the American Podiatric Medical

Association. Vol 104. No. 6. Nov/Dec 2014
PANEL MEMBERS
Robert Snyder Andrew J. Applewhite Caroline Fife

DPM, MSc MD MD
Professor and Director of Clinical Research at Barry Medical Director at the Comprehensive Wound Chief Medical Officer of "Intellicure,"
University SPM and President of the Association for Center of Baylor University Medical Center and Executive Director of the U.S. Wound
the Advancement of Wound Care Registry
Robert G. Frykberg Desmond Bell Jeffrey Jensen

DPM, MPH DPM DPM
Chief of the Podiatry section and Podiatric Co-founder and Executive Director of the “Save A Director of research at the Barry University
Residency Director at the Carl T. Hayden Veterans Leg, Save A Life” Foundation School of Podiatric Medicine and
Affairs Medical Center in Phoenix, Arizona and developer of the first commercially viable
Adjunct Professor, Midwestern University Program in standardized Total Contact Casting kit
Podiatric Medicine
Lee C. Rogers Gregory Bohn James Wilcox

DPM MD RN
Co-director of the Amputation Prevention Center at Director of the Trinity Center for Wound Care and Director of Research & Quality for Medical
Valley Presbyterian Hospital and the medical director Hyperbaric Medicine at Trinity Bettendorf and Moline Affairs for Healogics, Inc.
of Paradigm Medical Management Clinics at Trinity Regional Medical Center
Snyder RJ, et al. The Management of Diabetic Foot Ulcers through Optimal Off-loading. Building Consensus Guidelines and Practical Recommendations to Improve Outcomes.
Journal of the American Podiatric Medical Association. Vol 104. No. 6. Nov/Dec 2014
WHY DEVELOP A NEW CONSENSUS?
The group met to develop a comprehensive, evidence-based consensus on

the optimal use of off-loading in DFU treatment because:
DFUs are a major and costly complication that can:

1 • Reduce quality of life (QOL)
• Result in amputations and death
There is a gap between evidence and practice

2 with regards to the use of off-loading in the
treatment of DFUs
GOOD DFU MANAGEMENT
Begins with a comprehensive history and physical
Thorough wound assessment and treatment including:

• Management of peripheral arterial disease (PAD)
• Infection control and management
• Debridement
• Off-loading
• Maintaining a moist wound environment
Timely wound healing is less likely without

comprehensive management, including off-loading.
WHY OFF-LOADING?
Off-loading reduces both A diverse variety of off-loading devices

pressure on the foot and and techniques exists, including:
strain rate.
• Removable or non-removable devices
• Surgical techniques
• Other assistive devices, which lets the
clinician employ off-loading based on the
patient’s individual situation and needs
METHOD
The panel performed a From approximately 90

literature search of PubMed selected studies, 64 studies
articles for evidence on off- were included in the evidence
loading. tables, along with 3 additional
publications known by the
Inclusion criteria were based authors but not found in the
upon the support of the literature searches.
consensus statement.
METHOD
The panel used the GRADE1 approach to develop
strength of recommendation: The recommendation
levels are:
High: Moderate:
further research is very further research is ✔
unlikely to change likely to have an
confidence in the important impact on
Strong:
estimate of the effect confidence and may
patients should receive the
change the estimate
recommended action
Low:
further research is
very likely to have an
Very Low:
any estimate of the
effect is very uncertain
?
important effect on the Weak:
confidence in the clinicians should evaluate the
estimate and is likely recommendation within the
to change the estimate context of a particular
patient’s situation
GRADE = Grades of Recommendation, Assessment, Development, and Evaluation
1. Atkins D, et al. Grading quality of evidence and strength of recommendations. BMJ. 2004 Jun 19;328(7454):1490.
2. Snyder RJ, et al The Management of Diabetic Foot Ulcers through Optimal Off-loading. Building Consensus Guidelines and Practical Recommendations to Improve Outcomes.
Results
Eight evidence-based consensus guidelines
and core recommendations resulted from the
collaborative work of the panel.
Each statement references the level of the
evidence and the strength of the
recommendation - e.g., Moderate/Strong.
CONSENSUS STATEMENTS
Grade Recommendation
The VIPs (vascular management,

infection management and
1 prevention, and pressure relief)
are essential to DFU healing
✔
Adequate off-loading increases the

2 likelihood of DFU healing ✔
The panel endorses the Charcot

3 foot in diabetes consensus report1
The Charcot Foot in Diabetes
✔
ADA & APMA Guidelines
Diabetes Care, 2011
Total contact casting (TCC) is the preferred

4 method for off-loading diabetic plantar foot ✔
ulcers, as it has most consistently
demonstrated the best healing outcomes
and is a cost-effective treatment
1. Rogers LC, Frykberg RG, Armstrong DG, et al. The Charcot foot in diabetes. J Am Podiatr Med Assoc. 2011;101(5):437–46. Review.
2. Snyder RJ, et al The Management of Diabetic Foot Ulcers through Optimal Off-loading. Building Consensus Guidelines and Practical Recommendations to Improve Outcomes.
There currently exists a “gap”

5 between the evidence supporting
the efficacy of DFU off-loading and ✔
what is performed in clinical practice
The likelihood of DFU healing is

6 increased with off-loading adherence ✔
Advanced therapeutics are unlikely

7 to succeed in improving wound-
healing outcomes unless effective ✔
off-loading is achieved
The panel supports the

development of a per-visit off-
8 loading quality measure to address ✔
the gap between evidence of off-
loading and its current use in clinical
practice
KEY OUTCOMES
• Likelihood of healing is increased with off-loading

adherence
• The panel recommends TCC as the preferred

method for effective pressure relief
• Evidence consistently shows that when off-loading

is integrated into the patient encounter process
and provided at each visit, the likelihood of DFU
healing increases and the chance of complications
decreases
OFF-LOADING DEVICE AND
EVIDENCE REVIEW
EVIDENCE FOR OFF-LOADING DEVICES
AND TECHNIQUES
Removable Devices Evidence – Yes or No Level of Evidence
Walker cast (Stabil-D®) Yes46 Moderate
Shoe modification/custom-made temporary footwear Yes41,44,57 Moderate
Combinations of methods/techniques Yes19,31,32 Moderate
Fixed Ankle Walker (CAM/Bledsoe) Yes35,43 Low
Custom “CROW” (Charcot Restraint Orthotic Walker) Yes35 Low
DH Walker®, CAM boot shoe Yes20,35,43 Low
Air cast/pneumatic ankle/walking brace/splint Yes35,44,45 Low
Half Wedge shoe/Integrated Prosthetic and Orthotic System Yes19,35 Low
Diabetic shoe Yes45 Low
Felt and foam Yes35,44 Low
Custom Ankle Orthotic No -
Custom Hinged Device No -
Removable Cast Walker (tall/short) No -
Heel relief shoe No -
Surgical shoe No -
EVIDENCE FOR OFF-LOADING DEVICES
AND TECHNIQUES
Non-Removable Devices Evidence – Yes or No Level of Evidence
Total Contact Cast (TCC) (Example MedE-Kast® and TCC-EZ®) Yes1,3,5,19-21,31-35,37,38,43,44,47-49 Moderatea
Instant total contact cast, iTCC Yes1,5,19,20,29,31,34,36,39,40 Moderate
Scotchcast® 3M tape boot Yes3,50 Low
Soft total contact cast No -
Football dressing No -
Surgical Techniques Evidence – Yes or No Level of Evidence
Surgical procedures Yes4,20,31 Moderate
Debridement Yes43 Very low
External fixator No -
EXAMPLES OF REMOVABLE OFF-LOADING
DEVICES
Air Cast Pneumatic walker CAM Walker DH Walker
Half Wedge shoe

CROW walker
EXAMPLES OF NON-REMOVABLE OFF-
LOADING SYSTEMS
Plaster and fiberglass “instant Total Contact Cast”

Traditional TCC system Removable boot with coband
An easier to use, Roll-on (iTCC)
TCC system designed
for optimal off-loading
EXAMPLES OF REMOVABLE OFF-LOADING
DEVICES – WITH NO EVIDENCE
Surgical / Post-op shoe Custom ankle orthotic Heel relief shoe
OFF-LOADING DEVICES AND TECHNIQUES
WITH NO EVIDENCE
Other Assisted Devices Evidence – Yes or No Level of Evidence
Crutches No -
Canes No -
Walkers No -
Rolling walkers No -
Bed rest No -
Crutches Wheelchair
OFF-LOADING OPTIONS BY CONDITION
Products:
A: Total contact cast; B: CROW boot; C: Prefabricated walker; D: DH walker; E: IPOS shoe; F: Ortho wedge; G: PostOp shoe; H: Healing sandal; I: Reverse IPOS; J: L’nard splint;
K: PTB brace; L: MABAL shoe.
Location of DFU:
1: dorsal digit; 2: plantar digit; 3: plantar metatarsal; 4: medial metatarsal; 5: lateral metatarsal; 6: heel. Reproduced with permission by Ostomy Wound Management.35
Figure adapted from Snyder et al. Consensus Recommendations On Advancing The Standard Of Care For Treating Neuropathic Foot Ulcers in Patients With Diabetes. Ostomy Wound Management. 2010;56.
OFF-LOADING OPTIONS BY AMOUNT OF
EVIDENCE
A. B. C. D. E. F. G. H. I. J. K. L.
Products:
A: Total contact cast; B: CROW boot; C: Prefabricated walker; D: DH walker; E: IPOS shoe; F: Ortho wedge; G: PostOp shoe;
H: Healing sandal; I: Reverse IPOS; J: L’nard splint; K: PTB brace; L: MABAL shoe.
RECENT RCTs, META-ANALYSIS AND
RECOMMENDATIONS REGARDING
TOTAL CONTACT CASTING
PROVEN CLINICAL EFFICACY FOR TCC –
COCHRANE SYSTEMATIC REVIEW 2013
7 studies (366 participants)

comparing non-removable
casts with removable
pressure-relieving devices
In 5/7 studies, non-removable

casts were associated with a
statistically significant increase
in healed ulcers compared with
removable devices
Lewis J, et al. Pressure-relieving interventions for treating diabetic foot ulcers. Cochrane Database Syst Rev. 2013;1:CD002302
ADDITIONAL CLINICAL EFFICACY FOR TCC
Lavery AL, et al. Randomised clinical trial to compare total contact casts, healing
sandals and a shear-reducing removable boot to heal diabetic foot ulcers.
International Wound Journal 2014
Patient satisfaction was equal across devices.
Primary endpoint*: Patients achieving wound Secondary endpoint*: Average time to healing
closure with full epithelialization (N=73)
• 90% of patients with TCC 5.4 weeks for patients with TCC
• 50% of patients with a healing sandal 8.9 weeks for patients with a healing sandal
• 40% of patients with a shear-reducing 6.7 weeks for patients in a walking boot
walking boot
N=73
*‘Per-protocol analysis’ = only subjects who completed the study were included in the analysis.
Lavery AL, et al. Randomised clinical trial to compare total contact casts, healing sandals and a shear-reducing removable boot to heal diabetic foot ulcers. Int Wound J 2014.
PROVEN CLINICAL EFFICACY FOR TCC –
7 RCTs (N=371)
%
TCC has a healing rate of about
90% within 6–8 weeks*
*References
Armstrong DG, et al. Off-loading the diabetic foot wound. Diabetes Care 24:1019-1022, 2001.
Mueller NJ, et al. Effect of Achilles tendon lengthening on neuropathic plantar ulcers. Journal of Bone and Joint Surgery 85-A:8; 1436-1445, 2003.
Katz IA, et al. A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers. Diabetes Care 28:555-559, 2005.
Piaggesi A, et al. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers. Diabetes Care 30:586-590, 2007.
Mueller NJ, et al. Total contact casting in treatment of diabetic plantar ulcers; Controlled clinical trial. Diabetes Care 12:384-388, 1989.
Armstrong DG, et al. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds. Diabetes Care 28:551-554, 2005.
Lavery AL, et al. Randomised clinical trial to compare total contact casts, healing sandals and a shear-reducing removable boot to heal diabetic foot ulcers. Int Wound J 2014.
CAROLINE E. FIFE ET AL.
DIABETIC FOOT ULCER OFF-LOADING:
THE GAP BETWEEN EVIDENCE AND
PRACTICE
Data from the US Wound Registry 2007 - 2013
C. E. Fife, MD, et al, Diabetic foot ulcer off-loading: The Gap Between Evidence and Practice: Data from the U.S. Wound Registry.
Advances in Skin and Wound Care, 27(7) p. 310-316, 2014
USWR DFU “OFF-LOADING IN PRACTICE”
PROJECT
Off-loading
devices (2.2%)
(N = 4896)
Postoperative
TCC (16%) Others (47.2%)
shoes (36.8%)
(N = 781) (N = 2312)
(N = 1803)
Roll on cast - Traditional

TCC-EZ® (36%) casting (64%)
C. E. Fife, MD, et al, Diabetic foot ulcer off-loading: The Gap Between Evidence and Practice: Data from the U.S. Wound Registry.
Advances in Skin and Wound Care, 27(7) p. 310-316, 2014
USWR DFU ‘OFF-LOADING IN PRACTICE’
PROJECT
Patient outcomes
Amputations Infections (per year)
6 3
DFU patients who needed amputations (%)
P = 0.001* P = 0.0000000021 *
5 2.5
Infections (per year)

4 2
3 1.5
2 1
1 0.5
0 0
TCC Non-TCC TCC Non-TCC
* Data was not stratified
C. E. Fife, MD, et al, Diabetic foot ulcer off-loading: The Gap Between Evidence and Practice: Data from
the U.S. Wound Registry. Advances in Skin and Wound Care, 27(7) p. 310-316, 2014
GAP IN PRACTICE
3.7%
Despite extensive clinical
evidence documenting its efficacy,
TCC is not widely used!
Only 3.7% ‘TCC-eligible’

patients received TCC
96.3%
How can this be
Eligible DFUs treated with TCC
improved?
Eligible DFUs treated with non-TCC
methods
BARRIERS TO TCC
Clinician-related Patient-related Organizational

• Lack of skill • Reluctance • Cost
• Misperception that • Transportation • Hard to integrate
TCC delays healing issues (driving) into patient flow
• Staff training barriers • Heavy patients • Storage of supplies
• Cost and time vs. • Fear of falling
reimbursement
CHANGE THE PARADIGM TO OVERCOME
BARRIERS
Education of Patients and Clinicians
Consensus Statement: “Newer techniques that approximate
the effect of traditional TCC, and which are easier to use and
faster to apply, may increase the use of adequate off-loading in
clinical practice.”1
Based on Registry Data:

VS.
Four times more patients
were casted in clinics using
TCC-EZ® compared to
Traditional TCC TCC-EZ® traditional casts2
Novel “Roll-on” cast system
1. Snyder RJ, et al. The Management of Diabetic Foot Ulcers through Optimal Off-loading. Building Consensus Guidelines and Practical
Recommendations to Improve Outcomes. Journal of the American Podiatric Medical Association. Vol 104. No. 6. Nov/Dec 2014
2. C. E. Fife, MD, et al, Diabetic foot ulcer off-loading: The Gap Between Evidence and Practice: Data from the U.S. Wound Registry. Advances
in Skin and Wound Care, 27(7) p. 310-316, 2014
IMPLICATIONS FOR PRACTICE
Non-removable casts provide the most

1 effective pressure-relieving intervention for
the healing of DFUs.
TCC is a cost-effective method for DFU

2 treatment.
Use of this intervention has to be balanced

3 against restrictions in movement, although
patients may still be able to work and carry
out daily activities.
Where non-removable casts are not

4 indicated (i.e. fall risks) or have not been
successful, other interventions — such as
removable devices, adhesive felt, or “off-
loading” surgery — should be considered.
GENERAL RECOMMENDATIONS
Off-loading with casts as well as aggressive off-

1 loading with other studied methods need to be more
widely adopted in clinical practice
Due to the increased likelihood of healing, TCC is

2 recommended as the preferred method for effective
pressure relief. Newer, easier to apply cast should be
considered to overcome barriers to use
More education is needed for the clinician and the

3 patients to increase off-loading use and
compliance
3. Andrew J. Applewhite, MD
• Off-loading in practice
• Practical Implementation in a clinic
USING TCC AS FIRST LINE TREATMENT
• Fear: Fear is probably one of biggest

hurdles to TCC being used as first line
treatment for off-loading DFUs
• With TCC-EZ®, we overcame those

fears. TCC is standard of care at Baylor.
Close to 90% of our DFU patients get a
cast
OVERCOMING BARRIERS TO TCC
Clinician-related Patient-related Organizational

TCC-EZ® MAKES TCC EASIER
TCC-EZ® offers the

GOLD Standard of care
3 easy steps: prep, roll & apply
Completed in under 10 minutes
Ease & consistency of application helps to

decrease potential for causing tissue damage
Requires minimal training time
Light-weight woven design offers a more

comfortable fit
Jensen J, et al. TCC-EZ – Total Contact Casting System Overcoming the

Barriers to Utilizing a Proven Gold Standard Treatment. DF Con. 2008
PATIENT SELECTION
HOW IT WORKS
• Casting in practice
• Cast 5-10 patients per day
• 60% of patients have DFUs
• Eventually 85-90% of patients will wear a TCC-EZ®
• TCC is the first line treatment for off-loading
• Patient Push Back

• Talk with confidence to patient and family - explain that TCC is the
treatment of choice
• Mortality is much higher for a DFU than a broken leg and with a
broken leg you would expect to be casted
• Consider use of other advanced technologies in conjunction with off-

loading
• TCC in conjunction with CTP (Cellular- and/or Tissue-based Products)
• TCC in conjunction with HBO
PATIENT FLOW
A BUSY METROPOLITAN WOUND CARE CENTER HAS
SUCCESSFULLY INCORPORATED A ROLL-ON TOTAL CONTACT
CAST SYSTEM TO HEAL CHALLENGING FOOT WOUNDS
1. This case series will describe 14 patients that were treated with Total Contact Casting (TCC)
to heal their challenging foot ulcers.
2. This case series will illustrate how integrating a scientifically proven modality such as TCC can
lead to positive outcomes in healing diabetic foot ulcers in an outpatient wound care setting.
Methods:
This series describes 14 patients with diabetic foot wounds. The wounds range in chronicity from
4 weeks to 1 1/2 years prior to being treated with TCC. The clinic staff were educated on the use
of the Roll-on TCC Cast System. Wound assessment, debridement and topical wound therapy
were used based on moist wound healing principles.1 Foot wounds and Charcot foot
arthropathy2 were successfully off-loaded with the Roll-on TCC System to produce optimal
patient outcomes.
Clinical Poster Presented SAWC Fall, 2014
References: 1. Bryant RA, Nix DP. Acute and Chronic Wounds: Current Management Concepts. 4th Edition. St. Louis, MO: Mosby Elsevier, 2012. 2. Rogers LC, et al:
The Charcot Foot in Diabetes. Diabetes Care 34:2123-2129, 2011.
CASE 1
This 58-year-old female was admitted for osteomyelitis of first metatarsal head. She
refused a toe amputation. After 6 weeks of IV antibiotics she agreed to proper off-
loading and her wound healed in 8 weeks.
1.29.14 3.12.14 – 1st TCC application 5.07.14

CASE 2
This 49-year-old female was diagnosed with osteomyelitis and peripheral artery
disease. After stent placement and IV antibiotics she was still reluctant to wear a
cast. Once she agreed, she experienced healing in 8 weeks with Roll-on TCC.
3.26.14 4.24.14 5.28.14

14 PATIENT CASE SERIES
INCORPORATING TCC-EZ®
The clinical staff at this wound care center have incorporated casting so well that even
casting a post TMA patient, as seen below, is not difficult or a time consuming process.
Each component of application and removal only takes a matter of minutes.
This TMA patient’s wound The stockinette has been The patient was turned to a prone
was dressed and an extra applied. position and the doctor is shown The patient is ready to
foam dressing was applied here rolling on the cast. go with dried cast and
to the patient’s shin area.
boot for ambulation.
Total Wound Care Visit, Including TCC-EZ® = 30 minutes

FINAL RESULTS & CONCLUSION
• All 14 patients achieved complete wound closure after

implementation of TCC. Several wounds were healed in
4–6 weeks
• More complicated wounds took longer to heal as would

be expected
• This case series demonstrates successful treatment

regimens involving neuropathic and other complicated
foot wounds treated with the Roll-on TCC System
CONCLUSION
• Even in clinics that use TCC, it is often only
seen as last resort option when faced with
an amputation, instead of being a first line
treatment when indicated.
• The cost associated with DFUs are too high

for us not to stop patients climbing the
amputation staircase. As clinicians we need
to lead the way.
What is holding you back?

It’s a new year - will you make
TCC first line therapy in your
clinic?
QUESTIONS?
David G. Armstrong, DPM, MD, PhD

Professor of Surgery and Director
Southern Arizona Limb Salvage Alliance (SALSA)
University of Arizona College of Medicine
Robert Snyder, DPM, MSc

Professor and Director, Clinical Research
Barry University School of Podiatric Medicine
Past President, Association for the Advancement of Wound Care
Andrew J. Applewhite, MD
Medical Director, Comprehensive Wound Center of Baylor
University Medical Center
Find out more at about the leading casting system:

TCCEZ.com,
patient website TCCpatient.com
SUMMARY OF EVIDENCE
SUPPORTING THE CONSENSUS
REFERENCES
1. Snyder RJ, Kirsner RS, Warriner RA, 3rd, et al. Consensus recommendations on advancing the standard of care
for treating neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage. 2010;56:S1.
2. Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J
Foot Ankle Surg. 2006;45:S1.
3. Boulton AJ. Pressure and the diabetic foot: clinical science and offloading techniques. Am J Surg. 2004;187:17S.
4. Steed DL, Attinger C, Brem H, et al. Guidelines for the prevention of diabetic ulcers. Wound Repair Regen.
2008;16:169.
5. Cavanagh PR, Bus SA. Off-loading the diabetic foot for ulcer prevention and healing. J Vasc Surg. 2010;52:37S.
6. Bus SA. Priorities in offloading the diabetic foot. Diabetes Metab Res Rev. 2012;28:54.
7. Nabuurs-Franssen MH, Sleegers R, Huijberts MS, et al. Total contact casting of the diabetic foot in daily practice:
a prospective follow-up study. Diabetes Care. 2005;28:243.
8. Castronuovo JJ, Jr., Adera HM, Smiell JM, et al. Skin perfusion pressure measurement is valuable in the
diagnosis of critical limb ischemia. J Vasc Surg. 1997;26:629.
9. Gibbons GW, Shaw PM. Diabetic vascular disease: characteristics of vascular disease unique to the diabetic
patient. Semin Vasc Surg. 2012;25:89.
10. Sumpio BE, Aruny J, Blume PA. The multidisciplinary approach to limb salvage. Acta Chir Belg. 2004;104:647.
REFERENCES
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Med Surg. 2003;20:689.
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inpatient setting. J Am Podiatr Med Assoc. 1997;87:260.
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Rev. 2008;24:S192.
REFERENCES
20. Lewis J, Lipp A. Pressure-relieving interventions for treating diabetic foot ulcers. Cochrane Database Syst Rev 1:
CD002302, 2013.
21. Kirsner RS, Bell D, Gibbons G, et al. Expert recommendations for optimizing outcomes utilizing Apligraf® for
diabetic foot ulcers. 2012; www.woundresearch.com/pdfs/wounds_orgo.pdf. Accessed May 30, 2013.
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New Clinical Guidelines Off-Load and Help Heal Diabetic Foot Ulcers

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New Clinical Guidelines Off-Load and Help Heal Diabetic Foot Ulcers

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NEW CLINICAL GUIDELINES TO OFF-LOAD & HELP

HEAL DIABETIC FOOT ULCERS:

David G. Armstrong, DPM, MD, PhD

Robert Snyder, DPM, MSc

This educational event is supported by Derma Sciences Inc.

1. David Armstrong, DPM, MD, PhD

2. Rob Snyder, DPM, MSc

1. David Armstrong, DPM, MD, PhD

In 2011, 26 million 15% of patients

45% 5-year mortality 85% of lower extremity

1. Centers for Disease Control. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.

• Nearly 80,000 LEAs are performed on diabetics

• Two-year costs associated with initial

• The projected lifetime health care cost for the

1. What am I going to take off this wound that might

2. What can I put on this wound that might help it

3. How can I prevent (severe) recurrence?

2. Rob Snyder, DPM, MSc

Journal of the American Podiatric Medical

Robert Snyder Andrew J. Applewhite Caroline Fife

Robert G. Frykberg Desmond Bell Jeffrey Jensen

Lee C. Rogers Gregory Bohn James Wilcox

The group met to develop a comprehensive, evidence-based consensus on

DFUs are a major and costly complication that can:

There is a gap between evidence and practice

Begins with a comprehensive history and physical

Thorough wound assessment and treatment including:

Timely wound healing is less likely without

Off-loading reduces both A diverse variety of off-loading devices

The panel performed a From approximately 90

The VIPs (vascular management,

Adequate off-loading increases the

The panel endorses the Charcot

Total contact casting (TCC) is the preferred

There currently exists a “gap”

The likelihood of DFU healing is

Advanced therapeutics are unlikely

The panel supports the

• Likelihood of healing is increased with off-loading

• The panel recommends TCC as the preferred

• Evidence consistently shows that when off-loading

Walker cast (Stabil-D®) Yes46 Moderate

Shoe modification/custom-made temporary footwear Yes41,44,57 Moderate

Combinations of methods/techniques Yes19,31,32 Moderate

Fixed Ankle Walker (CAM/Bledsoe) Yes35,43 Low

Custom “CROW” (Charcot Restraint Orthotic Walker) Yes35 Low

DH Walker®, CAM boot shoe Yes20,35,43 Low

Air cast/pneumatic ankle/walking brace/splint Yes35,44,45 Low

Half Wedge shoe/Integrated Prosthetic and Orthotic System Yes19,35 Low

Diabetic shoe Yes45 Low

Felt and foam Yes35,44 Low

Custom Ankle Orthotic No -

Custom Hinged Device No -

Removable Cast Walker (tall/short) No -

Heel relief shoe No -

Instant total contact cast, iTCC Yes1,5,19,20,29,31,34,36,39,40 Moderate

Scotchcast® 3M tape boot Yes3,50 Low

Soft total contact cast No -

Surgical Techniques Evidence – Yes or No Level of Evidence

Surgical procedures Yes4,20,31 Moderate

Debridement Yes43 Very low

Air Cast Pneumatic walker CAM Walker DH Walker

Half Wedge shoe

Plaster and fiberglass “instant Total Contact Cast”