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

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

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

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

1. 2. 3. 4.

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

85% of lower extremity amputations (LEAs) in diabetic patients are preceded by a foot ulcer3

Centers for Disease Control. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. National Diabetes Data Group: Diabetes in America, Vol. 2. Bethesda, MD, National Institutes of Health 1995 (NIH publ. no. 95-1468) Incidence of diabetic foot ulcer and lower extremity amputation among Medicare beneficiaries, 2006 to 2008, www.ahrq.gov. Centers for Disease Control http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.

5-YEAR MORTALITY VS. CANCER 97

100 86

Percent

80 64 55

60 45

47

48

40 18

20

18

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.

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

2. Rob Snyder, DPM, MSc • New consensus guidelines: DFU management through optimal offloading • 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 University SPM and President of the Association for the Advancement of Wound Care

Medical Director at the Comprehensive Wound Center of Baylor University Medical Center

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

Robert G. Frykberg

Desmond Bell

Jeffrey Jensen

DPM, MPH

DPM

DPM

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

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

Lee C. Rogers

Gregory Bohn

James Wilcox

DPM

MD

RN

Co-director of the Amputation Prevention Center at Valley Presbyterian Hospital and the medical director of Paradigm Medical Management

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

Director of Research & Quality for Medical Affairs for Healogics, Inc.

Chief 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

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:

1

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

2

There is a gap between evidence and practice with regards to the use of off-loading in the treatment of DFUs

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

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. 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 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

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

METHOD

The panel performed a literature search of PubMed articles for evidence on offloading. 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.

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

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

High:

Moderate:

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

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

Low:

Very Low:

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

any estimate of the effect is very uncertain

The recommendation levels are:

✔ Strong: patients should receive the recommended action

? Weak: clinicians should evaluate the recommendation within the context of a particular patient’s situation

GRADE = Grades of Recommendation, Assessment, Development, and Evaluation 1. 2.

Atkins D, et al. Grading quality of evidence and strength of recommendations. BMJ. 2004 Jun 19;328(7454):1490. 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

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.

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

CONSENSUS STATEMENTS

CONSENSUS STATEMENTS Grade

1

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

2

Adequate off-loading increases the likelihood of DFU healing

Recommendation

✔

✔

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

CONSENSUS STATEMENTS Grade

3

The panel endorses the Charcot foot in diabetes consensus report1

Recommendation

✔

The Charcot Foot in Diabetes ADA & APMA Guidelines Diabetes Care, 2011

4

1. 2.

Total 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

✔

Rogers LC, Frykberg RG, Armstrong DG, et al. The Charcot foot in diabetes. J Am Podiatr Med Assoc. 2011;101(5):437–46. Review. 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

CONSENSUS STATEMENTS Grade

5

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

6

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

Recommendation

✔

✔

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

CONSENSUS STATEMENTS Grade

7

8

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

The panel supports the development of a per-visit offloading quality measure to address the gap between evidence of offloading and its current use in clinical practice

Recommendation

✔

✔

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

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

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

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

-

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

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

Soft total contact cast

No

-

Football dressing

No

-

Surgical Techniques

Low

Evidence – Yes or No

Level of Evidence

Surgical procedures

Yes4,20,31

Moderate

Debridement

Yes43

Very low

External fixator

No

-

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

EXAMPLES OF REMOVABLE OFF-LOADING DEVICES

Air Cast Pneumatic walker

CAM Walker

Half Wedge shoe

DH Walker

CROW walker

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

EXAMPLES OF NON-REMOVABLE OFFLOADING SYSTEMS

Plaster and fiberglass Traditional TCC system An easier to use, Roll-on TCC system designed for optimal off-loading

“instant Total Contact Cast” Removable boot with coband (iTCC)

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

EXAMPLES OF REMOVABLE OFF-LOADING DEVICES – WITH NO EVIDENCE

Surgical / Post-op shoe

Custom ankle orthotic

Heel relief shoe

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

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

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

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. 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

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 closure with full epithelialization (N=73)

Secondary endpoint*: Average time to healing

• • •

5.4 weeks for patients with TCC 8.9 weeks for patients with a healing sandal 6.7 weeks for patients in a walking boot

90% of patients with TCC 50% of patients with a healing sandal 40% of patients with a shear-reducing 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 shoes (36.8%) (N = 1803)

TCC (16%) (N = 781)

Roll on cast TCC-EZ® (36%)

Others (47.2%) (N = 2312)

Traditional 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) 3

P = 0.001*

P = 0.0000000021 *

5

2.5

Infections (per year)

DFU patients who needed amputations (%)

6

4

3

2

2

1.5

1

1

0.5

0

0

TCC

Non-TCC

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

Non-TCC

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%

Eligible DFUs treated with TCC Eligible DFUs treated with non-TCC methods

How can this be improved?

BARRIERS TO TCC

Clinician-related

Patient-related

Organizational

• •

• •

• •

• •

Lack of skill Misperception that TCC delays healing Staff training barriers Cost and time vs. reimbursement

• •

Reluctance Transportation issues (driving) Heavy patients Fear of falling

•

Cost Hard to integrate into patient flow Storage of supplies

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

VS.

Traditional TCC

TCC-EZ®

Based on Registry Data: Four times more patients were casted in clinics using TCC-EZ® compared to 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

1

2 3

4

Non-removable casts provide the most effective pressure-relieving intervention for the healing of DFUs. TCC is a cost-effective method for DFU treatment. Use of this intervention has to be balanced against restrictions in movement, although patients may still be able to work and carry out daily activities. Where non-removable casts are not indicated (i.e. fall risks) or have not been successful, other interventions — such as removable devices, adhesive felt, or “offloading” surgery — should be considered.

GENERAL RECOMMENDATIONS

1

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

2

Due 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

3

More education is needed for the clinician and the patients to increase off-loading use and compliance

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

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

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 offloading • 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 offloading 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 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 to go with dried cast and 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? 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

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.

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