New Clinical Guidelines to Off-Load and Help Heal Diabetic ... · The Management of Diabetic Foot Ulcers through Optimal Off-loading. Building Consensus Guidelines and Practical Recommendations

NEW CLINICAL GUIDELINES TO OFF-LOAD & HELP HEAL DIABETIC FOOT ULCERS: ACTIONABLE EVIDENCE TO IMPROVE OUTCOMES

This educational event is supported by Derma Sciences Inc.

David G. Armstrong, DPM, MD, PhDProfessor of Surgery and DirectorSouthern Arizona Limb Salvage Alliance (SALSA)University of Arizona College of Medicine

Robert Snyder, DPM, MScProfessor and Director, Clinical ResearchBarry University School of Podiatric MedicinePast President, Association for the Advancement of Wound Care

Andrew J. Applewhite, MDMedical Director, Comprehensive Wound Center of Baylor University Medical Center

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 millionAmericans had diabetes (8.3% of the US population)1

15% of patients with diabetes are at risk of developing a foot ulcer (DFU)2

45% 5-year mortality rate post-LEA among diabetic patients4

85% of lower extremity amputations (LEAs) 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.

8

18 18

45 47 4855

64

86

97

0

20

40

60

80

100

Percent

Armstrong DG, Wrobel J, Robbins JM. Are diabetes-related wounds and amputations worse than cancer? Int Wound J. 2007;4(4):286–7.

5-YEAR MORTALITY VS. CANCER

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-LOADINGBuilding 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 SnyderDPM, MScProfessor and Director of Clinical Research at Barry University SPM and President of the Association for the Advancement of Wound Care

Robert G. FrykbergDPM, MPHChief of the Podiatry section and Podiatric Residency Director at the Carl T. Hayden Veterans Affairs Medical Center in Phoenix, Arizona and Adjunct Professor, Midwestern University Program in Podiatric Medicine

Lee C. RogersDPMCo-director of the Amputation Prevention Center at Valley Presbyterian Hospital and the medical director of Paradigm Medical Management

Andrew J. ApplewhiteMDMedical Director at the Comprehensive Wound Center of Baylor University Medical Center

Gregory BohnMDDirector of the Trinity Center for Wound Care and Hyperbaric Medicine at Trinity Bettendorf and Moline Clinics at Trinity Regional Medical Center

Caroline FifeMDChief Medical Officer of "Intellicure," and Executive Director of the U.S. Wound Registry

Jeffrey JensenDPMDirector of research at the Barry University School of Podiatric Medicine and developer of the first commercially viable standardized Total Contact Casting kit

Desmond BellDPMCo-founder and Executive Director of the “Save A Leg, Save A Life” Foundation

James WilcoxRNDirector of Research & Quality for MedicalAffairs for Healogics, Inc.

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:

1DFUs are a major and costly complication that can:• Reduce quality of life (QOL)• Result in amputations and death

2There is a gap between evidence and practice 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 pressure on the foot and

strain rate.

A diverse variety of off-loading devices and techniques exists, including:

• 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 literature search of PubMed articles for evidence on off-loading.

Inclusion criteria were based upon the support of the consensus statement.

From approximately 90 selected studies, 64 studies were included in the evidence tables, along with 3 additional publications known by the authors but not found in the literature searches.


METHOD

The panel used the GRADE1 approach to develop strength of recommendation: The recommendation

levels are:

✔✔✔✔

High:further research is very unlikely to change confidence in the estimate of the effect

Moderate: further research is likely to have an important impact on confidence and may change the estimate

Low: further research is very likely to have an important effect on the confidence in the estimate and is likely to change the estimate

Very Low: any estimate of the effect is very uncertain

Strong: patients should receive the

recommended action

Weak: clinicians should evaluate the recommendation within the

context of a particular patient’s situation

?

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.


GRADE = Grades of Recommendation, Assessment, Development, and Evaluation

ResultsEight 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


1

The VIPs (vascular management, infection management and prevention, and pressure relief) are essential to DFU healing

2Adequate off-loading increases the likelihood of DFU healing

Grade Recommendation

✔✔✔✔

✔✔✔✔



3The panel endorses the Charcot foot in diabetes consensus report1

The Charcot Foot in Diabetes

ADA & APMA GuidelinesDiabetes Care, 2011

4Total contact casting (TCC) is the preferred 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.


✔✔✔✔

✔✔✔✔


5There currently exists a “gap” between the evidence supporting the efficacy of DFU off-loading and what is performed in clinical practice

6The likelihood of DFU healing is increased with off-loading adherence


✔✔✔✔

✔✔✔✔



7Advanced therapeutics are unlikely to succeed in improving wound-healing outcomes unless effective off-loading is achieved

8

The panel supports the development of a per-visit off-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

CAM Walker

CROW walker

DH WalkerAir Cast Pneumatic walker

Half Wedge shoe


EXAMPLES OF NON-REMOVABLE OFF-LOADING SYSTEMS

An easier to use, Roll-on TCC system designed for optimal off-loading

“instant Total Contact Cast”Removable boot with coband

(iTCC)

Plaster and fiberglass Traditional TCC system


Heel relief shoe

EXAMPLES OF REMOVABLE OFF-LOADING DEVICES – WITH NO EVIDENCE

Surgical / Post-op shoe


Custom ankle orthotic

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 WheelchairSnyder 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

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

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.

A. B. C. D. E. F. L.G. H. I. J. K.


RECENT RCTs, META-ANALYSIS AND RECOMMENDATIONS REGARDING TOTAL CONTACT CASTING

PROVEN CLINICAL EFFICACY FOR TCC –COCHRANE SYSTEMATIC REVIEW 2013

Lewis J, et al. Pressure-relieving interventions for treating diabetic foot ulcers. Cochrane Database Syst Rev. 2013;1:CD002302

In 5/7 studies, non-removable casts were associated with a statistically significant increase in healed ulcers compared with removable devices

7 studies (366 participants) comparing non-removable casts with removable pressure-relieving devices

ADDITIONAL CLINICAL EFFICACY FOR TCC

Primary endpoint*: Patients achieving wound closure with full epithelialization (N=73)

• 90% of patients with TCC• 50% of patients with a healing sandal• 40% of patients with a shear-reducing

walking boot

Secondary endpoint*: Average time to healing

5.4 weeks for patients with TCC 8.9 weeks for patients with a healing sandal6.7 weeks for patients in a walking boot

%

Patient satisfaction was equal across devices.

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.

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

N=73*‘Per-protocol analysis’ = only subjects who completed the study were included in the analysis.

TCC has a healing rate of about

90% within 6–8 weeks*

PROVEN CLINICAL EFFICACY FOR TCC –7 RCTs (N=371)

*ReferencesArmstrong 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 PRACTICEData 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)

TCC (16%)(N = 781)

Postoperative shoes (36.8%)

(N = 1803)

Others (47.2%)(N = 2312)

Roll on cast -TCC-EZ® (36%)

Traditional casting (64%)


USWR DFU ‘OFF-LOADING IN PRACTICE’ PROJECT

Patient outcomes

* Data was not stratified

0

1

2

3

4

5

6

TCC Non-TCC

DF

U p

ati

en

ts w

ho

ne

ed

ed

am

pu

tati

on

s (

%)

Amputations

0

0.5

1

1.5

2

2.5

3

TCC Non-TCC

Infe

cti

on

s (

pe

r ye

ar)

Infections (per year)

P = 0.001* P = 0.0000000021 *


Despite extensive clinical evidence documenting its efficacy, TCC is not widely used!

Only 3.7% ‘TCC-eligible’ patients received TCC

How can this be improved?

GAP IN PRACTICE

3.7%

96.3%

Eligible DFUs treated with TCC

Eligible DFUs treated with non-TCCmethods

BARRIERS TO TCC

Clinician-related

• Lack of skill• Misperception that

TCC delays healing• Staff training barriers• Cost and time vs.

reimbursement

Patient-related

• Reluctance• Transportation

issues (driving)• Heavy patients• Fear of falling

Organizational

• Cost• Hard to integrate

into patient flow• Storage of supplies

CHANGE THE PARADIGM TO OVERCOME BARRIERS

Based on Registry Data:

Four times more patients were casted in clinics using

TCC-EZ® compared to traditional casts2

Traditional TCC TCC-EZ®

Novel “Roll-on” cast system

VS.

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

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

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

Education of Patients and Clinicians

IMPLICATIONS FOR PRACTICE

1Non-removable casts provide the most effective pressure-relieving intervention for the healing of DFUs.

3Use of this intervention has to be balanced against restrictions in movement, although patients may still be able to work and carry out daily activities.

4Where non-removable casts are not 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.

2TCC is a cost-effective method for DFU treatment.

GENERAL RECOMMENDATIONS

1Off-loading with casts as well as aggressive off-loading with other studied methods need to be more widely adopted in clinical practice

2Due to the increased likelihood of healing, TCC is recommended as the preferred method for effective pressure relief. Newer, easier to apply cast should be considered to overcome barriers to use

3More education is needed for the clinician and the 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

Clinician-related Patient-related Organizational

OVERCOMING BARRIERS TO TCC

TCC-EZ® MAKES TCC EASIER

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

Barriers to Utilizing a Proven Gold Standard Treatment. DF Con. 2008

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

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 useof 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.

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.

Clinical Poster Presented SAWC Fall, 2014

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.

CASE 1

1.29.14 3.12.14 – 1st TCC application 5.07.14

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.

CASE 2

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 was dressed and an extra foam dressing was applied to the patient’s shin area.

The stockinette has been applied.

The patient was turned to a prone position and the doctor is shown here rolling on the cast.

The patient is ready togo with dried cast andboot 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?

Find out more at about the leading casting system:

TCCEZ.com,patient website TCCpatient.com

David G. Armstrong, DPM, MD, PhDProfessor of Surgery and DirectorSouthern Arizona Limb Salvage Alliance (SALSA)University of Arizona College of Medicine

Robert Snyder, DPM, MScProfessor and Director, Clinical ResearchBarry University School of Podiatric MedicinePast President, Association for the Advancement of Wound Care

Andrew J. Applewhite, MDMedical Director, Comprehensive Wound Center of Baylor University Medical Center

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

11. Sumpio BE, Lee T, Blume PA. Vascular evaluation and arterial reconstruction of the diabetic foot. Clin Podiatr

Med Surg. 2003;20:689.

12. Schaper NC, Andros G, Apelqvist J, et al. Diagnosis and treatment of peripheral arterial disease in diabetic patients with a foot ulcer. A progress report of the International Working Group on the Diabetic Foot. Diabetes

Metab Res Rev. 2012;28:218.

13. Bakker K, Apelqvist J, Schaper NC. Practical guidelines on the management and prevention of the diabetic foot 2011. Diabetes Metab Res Rev. 2012;28:225.

14. Frykberg RG, Wittmayer B, Zgonis T. Surgical management of diabetic foot infections and osteomyelitis. Clin

Podiatr Med Surg. 2007;24:469.

15. Lipsky BA, Berendt AR, Cornia PB, et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54:e132.

16. Lipsky BA, Peters EJ, Berendt AR, et al. Specific guidelines for the treatment of diabetic foot infections 2011. Diabetes Metab Res Rev. 2012;28:234.

17. Eneroth M, Apelqvist J, Stenstrom A. Clinical characteristics and outcomes in 223 diabetic patients with deep foot infections. Foot Ankle Int. 1997;18:716.

18. Edelson GW, Armstrong DG, Lavery LA, et al. The acutely infected diabetic foot is not adequately evaluated in an inpatient setting. J Am Podiatr Med Assoc. 1997;87:260.

19. Bus SA, Valk GD, van Deursen RW, et al. Specific guidelines on footwear and offloading. Diabetes Metab Res

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.

22. Rathur HM, Boulton AJ. Pathogenesis of foot ulcers and the need for offloading. Horm Metab Res. 2005;37:61.

23. Armstrong DG, Holtz-Neiderer K, Wendel C, et al. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007;120:1042.

24. Lavery LA, Armstrong DG. Temperature monitoring to assess, predict, and prevent diabetic foot complications. Curr Diab Rep. 2007;7:416.

25. Lavery LA, Higgins KR, Lanctot DR, et al. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007;30:14.

26. Zou D, Mueller MJ, Lott DJ. Effect of peak pressure and pressure gradient on subsurface shear stresses in the neuropathic foot. J Biomech. 2007;40:883.

27. Landsman AS, Meaney DF, Cargill RS, 2nd et al. 1995 William J. Stickel Gold Award. High strain rate tissue deformation. A theory on the mechanical etiology of diabetic foot ulcerations. J Am Podiatr Med Assoc.

1995;85:519.

REFERENCES

28. Bus SA, Waaijman R, Arts M, et al. Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial. Diabetes Care. 2013;36:4109.

29. Katz IA, Harlan A, Miranda-Palma B, et al. A randomized trial of two irremovable offloading devices in the management of neuropathic diabetic foot ulcers. Diabetes Care. 2005;28:555.

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New Clinical Guidelines to Off-Load and Help Heal Diabetic ... · The Management of Diabetic Foot Ulcers through Optimal Off-loading. Building Consensus Guidelines and Practical Recommendations