evidenced based wound care

Evidenced Based Wound CareEvidenced Based Wound Care

Robert S. Kirsner, M.D., PhDRobert S. Kirsner, M.D., PhDDepartment of Dermatology and Cutaneous SurgeryDepartment of Dermatology and Cutaneous Surgery

Department of Epidemiology and Public HealthDepartment of Epidemiology and Public Health

University of Miami Miller School of Medicine University of Miami Miller School of Medicine

Miami, FloridaMiami, Florida

University of Miami/University of Miami/

Jackson Memorial Medical CenterJackson Memorial Medical Center

How Do We Make Decisions About What to How Do We Make Decisions About What to Use in a Wound?Use in a Wound?

Randomized Controlled Trials are the Gold StandardRandomized Controlled Trials are the Gold Standard

What’s The EvidenceWhat’s The Evidence

US Preventative Services Task Force. Guide to Clinical Preventative Services. 1996Gray M, et al. J WOCN 2004;31:53-61

Vacuum Assisted Closure for Pressure Ulcers

Silver dressings for pressure ulcers

What is Evidence Based Medicine?What is Evidence Based Medicine?

The conscientious, explicit and judicious use of The conscientious, explicit and judicious use of current best evidence in making decisions current best evidence in making decisions about the care of individual patientsabout the care of individual patients11

This impliesThis implies An analysis of the strengths and weaknesses An analysis of the strengths and weaknesses of scientific medical studies of scientific medical studies Proper interpretation when communicating Proper interpretation when communicating treatment choices to the patienttreatment choices to the patient

1. Centre for Evidence-Based Medicine1. Centre for Evidence-Based Medicine

Why Do We Need EBM?Why Do We Need EBM?

A clinical practice deemed effective based on A clinical practice deemed effective based on common sense or experience may, in fact, be common sense or experience may, in fact, be ineffective, or even harmfulineffective, or even harmful

Improvements may be for reasons other than Improvements may be for reasons other than the interventionthe intervention

– The placebo effectThe placebo effect– Natural resolution of the conditionNatural resolution of the condition

The proper use of available evidence should The proper use of available evidence should aide (not replace!) clinician training and aide (not replace!) clinician training and experienceexperience

What EBM is NotWhat EBM is Not

‘‘Ivory tower’ medicine confined to academic and Ivory tower’ medicine confined to academic and research centersresearch centers

Beyond the reach of the average practitioner Beyond the reach of the average practitioner ‘‘Cookbook’ medicineCookbook’ medicine

– The use of guidelines and protocols can simplify The use of guidelines and protocols can simplify the EBM process for the average practitionerthe EBM process for the average practitioner

Cost-cutting medicineCost-cutting medicine– The practice of EBM frequently results in The practice of EBM frequently results in

significant cost savings (good medicine is cost-significant cost savings (good medicine is cost-efficient)efficient)

Components of EBMComponents of EBM

Step 1: Ask a question:Step 1: Ask a question:

– Does the use of bioengineered tissue lead Does the use of bioengineered tissue lead to improved healing in patients with diabetic to improved healing in patients with diabetic foot ulcers?foot ulcers?

– What is the treatment for venous ulcers?What is the treatment for venous ulcers?

– Is debridement important in chronic wound Is debridement important in chronic wound care?care?


Step 2: Track down the best evidence to answer Step 2: Track down the best evidence to answer that question using:that question using:

– www.pubmed.govwww.pubmed.gov

– www.cochrane.orgwww.cochrane.org

– www.cebm.netwww.cebm.net

– www.ovid.comwww.ovid.com

– www.guideline.govwww.guideline.gov

– Etc., etc., etc.Etc., etc., etc.

Growth Factors With Positive Results in RCTGrowth Factors With Positive Results in RCT

Acute WoundsAcute Wounds

Donor SitesDonor Sites

EGFEGF

GHGH

Burn WoundsBurn WoundsFGFFGF

Punch Biopsy SitesPunch Biopsy Sites

PDGFPDGF

Chronic WoundsChronic Wounds

Venous Leg UlcersVenous Leg Ulcers

GM-CSFGM-CSF

CGRP+VIPCGRP+VIP

Diabetic Foot UlcersDiabetic Foot Ulcers

PDGFPDGF

EGFEGF

NGF (foot ulcers)NGF (foot ulcers)


Step 3: Critically evaluate the evidence for its Step 3: Critically evaluate the evidence for its validity, importance, and usefulness in clinical validity, importance, and usefulness in clinical practicepractice

Step 4: Integrate the critical evaluation with Step 4: Integrate the critical evaluation with your clinical expertise and the patient’s your clinical expertise and the patient’s individual problems/needsindividual problems/needs

Is Time an Issue? Is Time an Issue? Read Systematic Reviews!Read Systematic Reviews!

A systematic review is a summary of the medical A systematic review is a summary of the medical literature that uses explicit methods to perform literature that uses explicit methods to perform a thorough literature search and critical a thorough literature search and critical appraisal of individual studies.appraisal of individual studies.

A meta-analysis may be performed as well. This A meta-analysis may be performed as well. This is a systematic review that uses statistical is a systematic review that uses statistical methods to summarize the results.methods to summarize the results.

Cochrane CollaborationCochrane Collaboration

www.cochrane.org

Wounds groupWounds group

Summaries for freeSummaries for free

Fee for full reportFee for full report

http://www.cochrane.org/

EBM: Levels of EvidenceEBM: Levels of Evidence(US Preventive Services Taskforce)(US Preventive Services Taskforce)

Level I: at least one Level I: at least one randomized controlled trialrandomized controlled trial

Level II-1: controlled trials Level II-1: controlled trials without randomizationwithout randomization

Level II-2: Level II-2: cohort or case-control cohort or case-control analytic studiesanalytic studies– preferably from more than one center or research grouppreferably from more than one center or research group

Level II-3: Level II-3: multiple time series multiple time series with / without interventionwith / without intervention– Includes dramatic results in uncontrolled trialsIncludes dramatic results in uncontrolled trials

Level III: Level III: Opinions of respected authorities Opinions of respected authorities based on based on

– Clinical experienceClinical experience

– Descriptive studiesDescriptive studies

– Reports of expert committeesReports of expert committees

Strength of Strength of EvidenceEvidence(Wound Healing Society)(Wound Healing Society)

Level I: Meta-analysis or at least two Level I: Meta-analysis or at least two randomized controlled trials (RCT)randomized controlled trials (RCT)

Level II: At least one RCT and at least one Level II: At least one RCT and at least one significant seriessignificant series

Level III: Suggestive data supporting Level III: Suggestive data supporting principle, but lacking meta-analyses, RCT principle, but lacking meta-analyses, RCT or multiple clinical seriesor multiple clinical series

Clinical Guidelines and/or AlgorithmsClinical Guidelines and/or Algorithms

Fast, accessible resource for clinicians to Fast, accessible resource for clinicians to make patient care decisionsmake patient care decisions

Usually the result of multidisciplinary Usually the result of multidisciplinary teamworkteamwork

Released by governmental agencies, Released by governmental agencies, professional organizations, universities, professional organizations, universities, individual authorsindividual authors

May vary in regards to strength of scientific May vary in regards to strength of scientific evidenceevidence

Eddy DM. Health Affairs 2005;24:9-17

Wound Healing Society– www.woundheal.org

Association for the Advancement

of Wound Care– WWW.AAWCONE.COM

Venous UlcersVenous UlcersClinical Guidelines and/or AlgorithmsClinical Guidelines and/or Algorithms

Summary Algorithm for Venous Ulcer Care with Annotations of Available Evidence

Guidelines for the treatment of venous ulcers Robson et al., Wound Repair Regen. 2006;14:649-62

Validation of a Venous Ulcer GuidelineValidation of a Venous Ulcer Guideline

Both UK and US wound care settingsBoth UK and US wound care settings Retrospective pre-guideline group (n=80 pts)Retrospective pre-guideline group (n=80 pts) Prospective guideline treated group (n=80 pts)Prospective guideline treated group (n=80 pts)

– ABI: pre=8-36% post=93-96% ABI: pre=8-36% post=93-96% – % healed increased % healed increased

• 23% to 70% in the US 23% to 70% in the US • 40% to 65% in the UK40% to 65% in the UK

– Cost decreased Cost decreased • $825 to $113 in the US $825 to $113 in the US • £136 to £78 in the UK£136 to £78 in the UK

Better Outcomes and More Cost-EffectiveBetter Outcomes and More Cost-Effective

McGuckin, M., et al., Validation of venous leg ulcer guidelines in the United States and United McGuckin, M., et al., Validation of venous leg ulcer guidelines in the United States and United Kingdom. Am J Surg, 2002. 183(2): p. 132-7.Kingdom. Am J Surg, 2002. 183(2): p. 132-7.

Wound Healing Society GuidelinesWound Healing Society Guidelines

Diagnosis

Gross arterial disease should be ruled out by Gross arterial disease should be ruled out by establishing that pedal pulses are present establishing that pedal pulses are present and/or that the ankle brachial index (ABI) is and/or that the ankle brachial index (ABI) is >0.8.>0.8.

Mixed Arterial and Venous Ulcer

5-year Mortality Rate5-year Mortality Rate

16% 18%26%

38%

86%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

BreastCancer

Hodgkin'sDisease

PAD Colon andRectalCancer

LungCancer

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American Cancer Society Facts and Figures 2000.American Cancer Society Facts and Figures 2000.Kempczinski RF, Bernhard VM. Introduction and general considerations. In: Rutherford Kempczinski RF, Bernhard VM. Introduction and general considerations. In: Rutherford

RB, ed. Vascular Surgery. 3RB, ed. Vascular Surgery. 3rdrd ed. Philadelphia, PA: WB Saunders; 1989:643-652. ed. Philadelphia, PA: WB Saunders; 1989:643-652.

DiagnosisDiagnosis

A biopsy should be obtained in a non healing wound to exclude other causes of ulcers that may mimic venous disease

Squamous Cell CarcinomaSquamous Cell Carcinoma

Venous Leg Ulcers – TreatmentsVenous Leg Ulcers – Treatments

Standard of careStandard of care

for VLUs is for VLUs is

multi-layered multi-layered

compression bandagescompression bandages

de Araujo T et al. Ann Intern Med. 2003 ;138):326-34Valencia IC et al. J Am Acad Dermatol 2001;44:401-21

TreatmentTreatment Compression increases ulcer healing rates Compression increases ulcer healing rates

compared with no compressioncompared with no compression Multi-layered systems are more effective Multi-layered systems are more effective

than single-layered systemsthan single-layered systems– Elastic is superior to nonelasticElastic is superior to nonelastic

High compression is more effective than High compression is more effective than low compressionlow compression

Cochrane Data Base

Nelson EA, et al., J Vasc Surg. 2007;45:134-141.

Single Layer vs. Four Layer BandageSingle Layer vs. Four Layer Bandage

Healing Ulcers In PracticeHealing Ulcers In Practice

30-60% of venous leg ulcers treated with 30-60% of venous leg ulcers treated with

multilayered compression multilayered compression

will heal in 6 months will heal in 6 months

Br J Surg. 2002;89:40-4. Arch Dermatol 1998;134:293-300Br J Surg. 2002;89:40-4. Arch Dermatol 1998;134:293-300

Debridement for VLU

Williams, D et al., Wound Rep Regen. 2005; 13:131-137.

Debridement Improves HealingDebridement Improves Healing

Addressing Bacteria in WoundsAddressing Bacteria in Wounds

Pre-TreatmentPre-Treatment 2 Weeks Post-Treatment 2 Weeks Post-Treatment

Several RCTs showed Cadexomer Iodine plus Compression

Speeds Healing

Drosou A, Falabella AF, Kirsner RS: Wounds 2003;15:149-166.

By week 4, Silver Foam reduced By week 4, Silver Foam reduced ulcer size by 45% vs. 29% for Control ulcer size by 45% vs. 29% for Control

Foam, p = 0.0344Foam, p = 0.0344

Improved healing

Rel

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rea

Weeks

Silver Foam Foam

Int Wound J 2005;2:64-73


Oral AgentsOral AgentsPentoxifyllinePentoxifylline

AspirinAspirin

Relative risk of healing with pentoxifylline compared with placebo (with compression therapy)

Jull et al Lancet 2002

Pentoxifylline vs. PlaceboPentoxifylline vs. Placebo

Pentoxifylline vs. PlaceboPentoxifylline vs. Placebo


Pentoxifylline Efficacy (400mg TID)Pentoxifylline Efficacy (400mg TID)


High Dose PentoxifyllineHigh Dose Pentoxifylline

p≤0.043

Vincent Falanga et al Wound Rep Reg 1999;7:208

Predicting HealingPredicting Healing

Carnac The MagnificentCarnac The Magnificent

Large Ulcers of Long Duration Difficult to HealLarge Ulcers of Long Duration Difficult to Heal

>5 cm>5 cm22 -- 1 point1 point

>6 months duration >6 months duration -- 1 point1 point

Thus a score or 0 to 2 was assigned to each ulcerThus a score or 0 to 2 was assigned to each ulcer

In the University of Pennsylvania data setIn the University of Pennsylvania data set

93% of patients healed - score of 093% of patients healed - score of 0

65% of patients healed - score of 1 65% of patients healed - score of 1

13% of patients healed - score of 2 13% of patients healed - score of 2 Margolis DJ, Berlin JA, Strom BL: Which venous leg ulcers will heal with limb compression. Margolis DJ, Berlin JA, Strom BL: Which venous leg ulcers will heal with limb compression.

Am J Med 2000;109:15-19Am J Med 2000;109:15-19..

Falanga V, Moneta G.Falanga V, Moneta G. Vasc Surg. Vasc Surg. 1999; 33:197-210.1999; 33:197-210.Falanga V, Sabolinski ML. Falanga V, Sabolinski ML. Wounds. Wounds. 2000; 12:42A-46A.2000; 12:42A-46A.Sheehan P, et al. Sheehan P, et al. Diabetes CareDiabetes Care. 2003;26(6):1879-1882.. 2003;26(6):1879-1882.

Other Predictors of Healing Other Predictors of Healing Healing rate at 4 weeks predicts Healing rate at 4 weeks predicts

overall healing rate overall healing rate

Initial healing rates of >0.1 Initial healing rates of >0.1 cm/wk correlate with healing cm/wk correlate with healing (40-50%)(40-50%)

Rapid identification of patients Rapid identification of patients who are unlikely to respond to who are unlikely to respond to conventional care allows for conventional care allows for earlier interventions with earlier interventions with advanced therapiesadvanced therapies

0.00.0

2.02.0

4.04.0

6.06.0

8.08.0

10.010.0

12.012.0

4/2

4/2

4/8

4/8

4/14

4/14

4/20

4/20

4/26

4/26 5/2

5/2

5/8

5/8

Area , cmArea , cm22

Advanced Therapy CriteriaAdvanced Therapy Criteria

When you switch a patient to more advanced When you switch a patient to more advanced therapies, you must ask:therapies, you must ask:

Which patients need this and when to intervene?Which patients need this and when to intervene?

Which product to use? Which product to use?

What is the evidence for the product chosen?What is the evidence for the product chosen?– Level of evidenceLevel of evidence– Strength of evidenceStrength of evidence– Approval typeApproval type– SafetySafety– EfficacyEfficacy

15 randomized controlled trials15 randomized controlled trials Total N=768 patients in the studiesTotal N=768 patients in the studies Compression used in 11 trialsCompression used in 11 trials Treatments:Treatments:

– Autologous skin graftAutologous skin graft– Frozen or fresh allograftsFrozen or fresh allografts– Bilayered skin cell therapy (n=345)Bilayered skin cell therapy (n=345)– Dermal cell replacement therapy (n=71)Dermal cell replacement therapy (n=71)– Porcine xenograftPorcine xenograft

Best Way to Heal VLUs with Grafts?Best Way to Heal VLUs with Grafts?

Jones JE et al Cochrane Database of Systematic Reviews 2007;1:CD001737.pub3 Univ of YorkJones JE et al Cochrane Database of Systematic Reviews 2007;1:CD001737.pub3 Univ of York

Meta-AnalysisMeta-Analysis

No evidence to indicate STSG is better than Standard of CareNo evidence to indicate STSG is better than Standard of Care

Jones JE et al Cochrane Database of Systematic Reviews 2007;1:CD001737.pub3 Univ of YorkJones JE et al Cochrane Database of Systematic Reviews 2007;1:CD001737.pub3 Univ of York

Meta-AnalysisMeta-Analysis

Apligraf increases probability of healing compared to Standard of CareApligraf increases probability of healing compared to Standard of Care

Cochrane Collaboration

A bilayered artificial skin (in A bilayered artificial skin (in conjunction with compression conjunction with compression

bandaging), increases the chance of bandaging), increases the chance of healing a venous ulcer compared with healing a venous ulcer compared with compression and a simple dressing.compression and a simple dressing.

TreatmentTreatment

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008 Weeks8 Weeks 12 Weeks12 Weeks 24 Weeks24 Weeks

Apligraf vs Compression TherapyApligraf vs Compression Therapy

Control (n=110) Control (n=110) Apligraf (n=130)Apligraf (n=130)

All Patients Achieving 100% ClosureAll Patients Achieving 100% Closure

ApligrafApligraf ®® in Venous Leg Ulcers in Venous Leg Ulcers

PP=.022=.022

4040

5757

By 24 weeks By 24 weeks PP=.022.=.022.Falanga V, et al. Falanga V, et al. Arch Dermatol.Arch Dermatol. 1998;134:293-300. 1998;134:293-300.

6060

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Control (n=48) Apligraf (n=72)

Falanga V. Sabolinski M. Falanga V. Sabolinski M. Wound Repair RegenWound Repair Regen. 1999;7:201-207.. 1999;7:201-207.

610 10

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ApligrafApligraf ®® In VLU of >1 Year Duration In VLU of >1 Year Duration

Care of the Diabetic Foot Ulcer

GLOBAL PROJECTIONS FOR THE DIABETES GLOBAL PROJECTIONS FOR THE DIABETES EPIDEMIC: 2003-2025 (millions)EPIDEMIC: 2003-2025 (millions)

25.0 39.759%

25.0 39.759%

10.419.788%

10.419.788%

38.244.216%

38.244.216%

1.11.7

59%

1.11.7

59%

13.6 26.998%

13.6 26.998%

WorldWorld 2003 = 189 million2003 = 189 million 2025 = 324 million2025 = 324 million

Increase 72%Increase 72%

81.8156.191%

81.8156.191%

18.235.997%

18.235.997%

14-20% patients will require a lower extremityamputation ~ 86,000 leg

amputations / year

85% amputations are preceded by a lower

extremity ulcer

15% (2.4 million) develop a foot ulcer during their lifetime

18.2 million diabetics(6.3% U.S. population)798,000 new cases/yr

Diabetic Neuropathic Ulcers

EBM for Diabetic Foot UlcerEBM for Diabetic Foot Ulcer

All patients with diabetes should have annual foot All patients with diabetes should have annual foot exams (at least)exams (at least)

Greater monitoring in at risk patientsGreater monitoring in at risk patients(neuropathy, vascular, history of(neuropathy, vascular, history ofulceration, foot deformities)ulceration, foot deformities)

Noninfected neuropathic ulcersNoninfected neuropathic ulcersrequire sharp debridement andrequire sharp debridement andpressure reductionpressure reduction

Ulcers with signs of infection require Ulcers with signs of infection require sharp debridement and deep culture sharp debridement and deep culture

Foot ulcers that are not responding withFoot ulcers that are not responding withappropriate wound care at appropriate wound care at 4 weeks4 weeks, should, shouldbe considered for adjuvant care (growthbe considered for adjuvant care (growthfactors, tissue engineered skin) and reassessedfactors, tissue engineered skin) and reassessed

Boulton AJM, Kirsner RS, Vileikyte L. N Engl J Med. 2004;351:48-55.

Guidelines for the Care of Patients Guidelines for the Care of Patients with Diabetic Foot Ulcerswith Diabetic Foot Ulcers

Multiple guidelines/algorithms:Multiple guidelines/algorithms:

– American Diabetes AssociationAmerican Diabetes Association

– American College of Foot and Ankle SurgeonsAmerican College of Foot and Ankle Surgeons

– Wound, Ostomy, Continence Nurses SocietyWound, Ostomy, Continence Nurses Society

– American Pharmaceutical AssociationAmerican Pharmaceutical Association

– American Orthopaedic Foot and Ankle SocietyAmerican Orthopaedic Foot and Ankle Society

– International Working Group on the Diabetic FootInternational Working Group on the Diabetic Foot

– Infectious Diseases Society of AmericaInfectious Diseases Society of America

– Wound Healing SocietyWound Healing Society

Protocol for Diabetic Foot Ulcer

Objective evaluation for ischemiaObjective evaluation for ischemia

Rule out osteomyelitisRule out osteomyelitis

Sharp debridementSharp debridement

Moist wound healing Moist wound healing

Off-loadingOff-loading

Amputations in Diabetic Foot InfectionsAmputations in Diabetic Foot Infections

Improved outcomes (healing) with decreased rates of Improved outcomes (healing) with decreased rates of major LEA and reduced LOS through multidisciplinary major LEA and reduced LOS through multidisciplinary team approach and/or Critical Pathwayteam approach and/or Critical Pathway

– Gibbons et al Arch Surg 1993 77% Gibbons et al Arch Surg 1993 77% – Larsson et al Diab Med 1995 78% Larsson et al Diab Med 1995 78% – Crane, Werber JFAS 1999 70% Crane, Werber JFAS 1999 70% – Holstein Diabetes Care 1999 ~80%Holstein Diabetes Care 1999 ~80%– Driver Diabetes Care 2005 Driver Diabetes Care 2005 ~82%~82%

Management Options for Offloading the Patient Management Options for Offloading the Patient With a Plantar UlcerWith a Plantar Ulcer

Complete bed rest

Wheel chair confinement

Crutches, walker (with protective footwear)

Wedge ShoeWedge Shoe

Ipos or Darco Wedge ShoeIpos or Darco Wedge Shoe

Surgical Shoe Surgical Shoe with Pressure Relief Insolewith Pressure Relief Insole

Darco med-surg shoe Darco med-surg shoe with ‘peg assist’ systemwith ‘peg assist’ system

Removable Cast Walker/Walking Boot

DH Walker – DH Walker – AKA Active Off-loading WalkerAKA Active Off-loading Walker

Cost $125 - 350

Total Contact Cast Total Contact Cast

Custom TCCCustom TCC

Total Contact Cast Total Contact Cast

ITCC – Instant Total Contact CastITCC – Instant Total Contact Cast

70

60

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Wounds 2000; 12(6 Suppl B): 32B

Mean Peak Pressure Metatarsal Heads

Contraindications Infection—Wagner Grade 3

Severe arterial disease

Inexperience of clinician applying the cast

Non-compliance

Skin conditions that precludes its use

Contact allergies

Osteomyelitis

Atrophic skin

Blindness

Obesity

Ataxia

Understanding and Improving Compliance Understanding and Improving Compliance With Off-loading:With Off-loading:

Diabetes Care 24:1019-1022, 2001Diabetes Care 24:1019-1022, 2001

Armstrong et al: Diabetes Care 24:1019-1022, 2001

http://care.diabetesjournals.org/content/vol24/issue6/images/large/dc0614178001.jpeg

Debridement of Diabetic Foot Ulcers Debridement of Diabetic Foot Ulcers

Debridement of Diabetic Foot Ulcers Debridement of Diabetic Foot Ulcers

5 RCTs of debridement were identified in The 5 RCTs of debridement were identified in The Cochrane Database Cochrane Database

3 RCTs assessed the effectiveness of a hydrogel 3 RCTs assessed the effectiveness of a hydrogel

1 RCT evaluated surgical debridement 1 RCT evaluated surgical debridement

1 RCT evaluated larval therapy. 1 RCT evaluated larval therapy.

Conclusion: Surgical debridement and larval Conclusion: Surgical debridement and larval therapy showed no significant benefit in therapy showed no significant benefit in these small trials. Hydrogel; no significant these small trials. Hydrogel; no significant evidenceevidence

The Cochrane Database of Systematic Reviews 2007 Issue 1

Benefit of DebridementBenefit of Debridement

Steed DT, et al., 1996

Debridement Performance Index

The Scoring System

3 categories: callus, edges & undermining, necrotic tissue

Saap & Falanga Wound Rep Reg 2002; 10(6):354-359

Score range (0-2)

0 Debridement needed & not done

1 Debridement needed & done

2 Debridement not needed

Debridement Performance IndexDebridement Performance Index

143 patients with diabetic wounds143 patients with diabetic wounds

Lower baseline Debridement Performance Index =Lower baseline Debridement Performance Index =

lower incidence of wound closure by week 12 (p=0.0276)lower incidence of wound closure by week 12 (p=0.0276)

Higher Debridement Performance Index Higher Debridement Performance Index

(3-6) 2.4 times more likely to heal than scores of 0-2 (3-6) 2.4 times more likely to heal than scores of 0-2

Saap & Falanga 2002 Wound Rep Regen; 10(6):354-359Saap & Falanga 2002 Wound Rep Regen; 10(6):354-359

Debridement to Normal TissueDebridement to Normal Tissue

Hyperkeratotic Hyperkeratotic TissueTissue

DebridementDebridement to to this Areathis Area

Tomic-Canic, Ayello, Stojadinovic et al (2008) ASWC in press

Diabetes Care. 1999;22:692-695Diabetes Care. 1999;22:692-695.

HEALING OF DIABETIC NEUROPATHIC FOOT ULCERS HEALING OF DIABETIC NEUROPATHIC FOOT ULCERS RECEIVING STANDARD TREATMENT:RECEIVING STANDARD TREATMENT:

A systematic review of the Control groups ofA systematic review of the Control groups of9 randomized clinical trials9 randomized clinical trials

Endpoints of complete closureEndpoints of complete closure

– At 12 weeks: 4 Control groupsAt 12 weeks: 4 Control groups

– At 20 weeks: 6 Control groupsAt 20 weeks: 6 Control groups– Complete closure in 24% and 31%, at

12 Weeks and 20 Weeks, respectively

Analysis of >26000 Diabetic Neuropathic Foot UlcersAnalysis of >26000 Diabetic Neuropathic Foot Ulcers

30-45% of diabetic foot ulcers heal in a 32 week 30-45% of diabetic foot ulcers heal in a 32 week periodperiod

Diabetes Care 2001;24:483-8Diabetes Care 2001;24:483-8

Wound Healing Trajectories as Predictors of Effectiveness of Therapeutic Agents Wound Healing Trajectories as Predictors of Effectiveness of Therapeutic Agents Robson MC, Hill DP, Woodske ME, Steed DL: Arch Surg 2000;135:773-777.







Adjunctive therapyAdjunctive therapy

FDA-Approved Treatments For DFUFDA-Approved Treatments For DFU

Regranex (1997)Regranex (1997)– PDGF-BBPDGF-BB

Apligraf (2000) Apligraf (2000) – Cultured Keratinocytes and Fibroblasts in Cultured Keratinocytes and Fibroblasts in

collagen matrixcollagen matrix

Dermagraft (2001) Dermagraft (2001) – Fibroblast on Vicryl MeshFibroblast on Vicryl Mesh

Steed DL, the Diabetic Ulcer Study Group; Clinical evaluation of recombinant

human platelet-derived growth factor for the treatment of lower extremity

diabetic ulcers. J Vasc Surg 1995;21:71-81.

Steed DL, the Diabetic Ulcer Study Group; Clinical evaluation of recombinant

human platelet-derived growth factor for the treatment of lower extremity

diabetic ulcers. J Vasc Surg 1995;21:71-81.

Regranex Incidence of Complete Healing of DFU Regranex Incidence of Complete Healing of DFU at 20 Weeksat 20 Weeks

CaseCase

Improved Healing With Tissue Improved Healing With Tissue Engineered Skin for Diabetic UlcersEngineered Skin for Diabetic Ulcers

Apligraf®Apligraf®Dermagraft®Dermagraft®

OR healing 1.7x OR healing 1.7x (p=0.044)(p=0.044)

Diabetes Care 2003;26:1701-5Diabetes Care 2003;26:1701-5 Diabetes Care 2001;24:290-295.Diabetes Care 2001;24:290-295.

OR healing 2.1x OR healing 2.1x (95% CI 1.23-3.74)(95% CI 1.23-3.74)

1818

1414

1010

66

44

22

00

1616

1212

88

PP<.05.<.05.

Veves A, et al. Veves A, et al. Diabetes CareDiabetes Care.. 2001;24:290-5.2001;24:290-5.

% o

f P

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% o

f P

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Incidence of Osteomyelitis at the Study Ulcer SiteIncidence of Osteomyelitis at the Study Ulcer Site

10.4%10.4%

2.7%2.7%

Lower Incidence of Osteomyelitis Lower Incidence of Osteomyelitis

Conventional therapy alone Conventional therapy alone (debridement, saline dressings, (debridement, saline dressings, total off-loading) [n=96]total off-loading) [n=96]

ApligrafApligraf® ® (n=112)(n=112)

PP<.05<.05

1818

1414

1010

66

44

22

00

1616

1212

88

PP<.05.<.05.

Veves A, et al. Veves A, et al. Diabetes CareDiabetes Care.. 2001;24:290-5.2001;24:290-5.

% o

f P

atie

nts

% o

f P

atie

nts

Lower Frequency of AmputationLower Frequency of Amputation

Conventional therapy alone Conventional therapy alone (debridement, saline dressings, (debridement, saline dressings, total off-loading) [n=96]total off-loading) [n=96]

Apligraf (n=112)Apligraf (n=112)

Frequency of Amputation/Resection of the Study LimbFrequency of Amputation/Resection of the Study Limb

15.6%15.6%

6.3%6.3%

PP<.05<.05

Frequency of Complete Wound Closure at 12 Weeks

ApligrafApligraf

Standard treatmentStandard treatment

3333

3939

5151

26260.0490.049

TreatmentTreatment NN%%

ClosedClosed

Fisher’sFisher’sExact TestExact Test(two-tailed)(two-tailed)

Edmonds M, et al. Edmonds M, et al. WoundsWounds. 2005:17(3) A43.. 2005:17(3) A43.

APLIGRAFAPLIGRAF®® DIABETIC FOOT ULCER EU STUDY DIABETIC FOOT ULCER EU STUDY

Phase IV StudiesPhase IV Studies

EvidenceEvidence•Patient dataPatient data

•Basic, clinical, and Basic, clinical, and epidemiological epidemiological

researchresearch•Randomized trialsRandomized trials

•Systematic reviewsSystematic reviews•Practice GuidelinesPractice Guidelines

Patient/Provider Patient/Provider FactorsFactors

•Cultural beliefsCultural beliefs•Personal valuesPersonal values

•ExperienceExperience•EducationEducation

ConstraintsConstraints•Policies, lawsPolicies, laws

•Community Community standardsstandards

•TimeTime•ReimbursementReimbursement

Clinical Clinical DecisionDecision

Elements of Medical Decision MakingElements of Medical Decision Making

Davidoff F. Mt. Sinai J Med 1999;66(2):75-83.

http://starcrest.org/links.htm

http://starcrest.org/links.htm

Average costAverage costper ulcer episode:per ulcer episode:

Diabetic Neuropathic UlcersDiabetic Neuropathic Ulcers

$8,000

$45,000

UncomplicatedUncomplicated

woundwound

If amputationIf amputationis requiredis required

Reiber GE, Boyko EJ, Smith DG. Lower Reiber GE, Boyko EJ, Smith DG. Lower Extremity Foot Ulcers and Amputations in Diabetes. Ulcers and Amputations in Diabetes. In Diabetes in America, 2nd edition. Bethesda, Md. National Diabetes Data Group, National In Diabetes in America, 2nd edition. Bethesda, Md. National Diabetes Data Group, National Institutes of Health, NIDDK, NIH Publication No. 95-1468, 1995.Institutes of Health, NIDDK, NIH Publication No. 95-1468, 1995.

ConclusionConclusion

Evidence based wound care uses Evidence based wound care uses techniques to answer a clinical techniques to answer a clinical problem for the betterment of problem for the betterment of

patient carepatient care

University of Miami

evidenced based wound care

Documents

ebm step

evidencebased medicine1

ebm process

venous ulcers

notwhat ebm

decisionscurrent best

inthe practice of ebm

based wound careevidenced