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Advances in healing of diabetic ulcersJ. Palmer Branch, DPMComprehensive Foot and Ankle, LLC www.comprehensivefootandankle.netDrCuboid@aol.com Lilburn, GA (770-921-8800) Cumming, GA (770-886-6833)

11Overview Key questions- Why do we care? / What is the problem? - Demographics- Costs- Healthcare expenses- Personal costs / debilitation

Why are diabetic patients at risk for foot ulcers?

What happens in the normal healing process?

Why do diabetic patients not heal as well as non-diabetics?

How do you examine the wound for potential problems?

- What can be done to enhance / expedite the healing process?- What types of advanced treatments and products are available?- When should advanced treatments be used?

- How can recurrent diabetic ulcers be prevented?

2Overview Additional commentsRecent advances in treatments for diabetic foot wounds have:Allowed the ability to heal limbs previously thought to be unsalvageable (e.g. Interventional arteriography / arterial stenting)

Enhanced the variety of treatment options to better individualize care for each situation and wound.

Provided a better recognition of the wound healing process.

Reduced the healing time Reduces risk of infection less window of opportunity Can reduce overall treatment cost

3Demographics - USAIn the US Diabetes has reached epidemic proportionsOver 16 million people diagnosed with diabetes8 million estimated undiagnosed15% of all diabetics will have a foot ulcer at some point in their livesPAD risk 2-6 times greater in diabetics. 6% of all diabetics undergo amputation 75% of all diabetic amputations are preventableIncreased 5 year mortality rate (18 to 55% higher in ischemic ulcers)

44Costs of diabetic limb amputationCosts average cost per amputation over $40,000 (Surgeon procedure fees only $750 1200)Estimated Cost - diabetic amputations in US $1 billion (2007)

Medical cost factors:Hospitalization- Home nursingSurgical procedures- Skilled nursing facilitiesProsthetic limbs- Recurrent problems

Other cost factorsLost wages short-term and long-termLost income tax revenues to federal / state / local governmentDependence on public assistance Medicaid, Social SecurityDepression, despondency, disruption of family.5Cardiac disease and foot ulcersIncreased cardiac workload after partial foot or leg amputation should not be quick to do this.

Cardiovascular disease has been found to be increased by amputation alone in populations not controlled for diabetics.Modnay & Peles -21.9 % vs. 12.1% over a 21-year time period in lower extremity traumatic amputees in military veterans

Question not answered well in literature: Is the increase in mortality from cardiac disease due to inactivity vs. the cardiac strain or some combination of factors?

6Risk factors for impaired wound healingPAD (peripheral arterial disease) 2-6 times more prevalent in DM.

Neuropathy lack of protective sensation, motor imbalance

Immunocompromised status

Structural problems focal pressure sitesContractures of toes, bunion deformitiesEquinus contractures tightness of the Achilles tendonCharcot joint / arthropathy

Other health factors7PAD and wound healing

The threshold circulation necessary for wound healing in the diabetic foot is systolic toe pressure 30-45mm Hg or ankle pressure 50-80mm Hg (ABI 0.40 0.66)

Arteriosclerosis in diabetics can cause noncompressible arterties leading to falsely elevated pressures on lower extremity arterial Doppler evaluation.

TcPO2 of 30mm Hg also mentioned frequently as a threshold value for wound healing. 8

Consider not only the quantity of blood getting to the wound, but also the quality of the blood.

Evaluate for systemic factorsanemia (CBC with differential)hypovolemiamalnutrition (albumin/prealbumin, total protein)hyperglycemia9Causes of ulcers - NeurologicLoss of protective sensation (LOPS)

Motor imbalances Dropfoot and other motor function alteration

Autonomic neuropathy

Charcot Arthropathy / Charcot Joint

10Venous UlcersVenous- Lack of return of venous blood to the heart- Fluid buildup / edema in the legs- Skin necroses due to underlyling venous pressure and buildup of waste products produces an ulceration.- Stasis dermatitis often noted in chronic cases- Compression a key to treatment

11Evaluation of the diabetic ulcer

12Evaluation of the diabetic ulcerSize length, width and depth

Probe to bone or visible bone clinical osteomyelitisGrayson - 75 patients, 76 ulcersSensitivity of 66% for osteomyelitisSpecificity of 85%Positive predictive value of 89%Negative predictive value of 56%.

13Evaluation of the diabetic ulcerCellulitis not always present in patients with PAD or immune compromise

Wound base quality eschar, granular, fibro-fatty

Malodor

Surrounding skin and wound margins14Evaluation of the diabetic ulcerLocation

Abscess visible or palpabletissue crepidus

Drainage typePurulent vs. serous Amount Healthy granular tissue normally has mild to moderate drainage.Heavy drainage may have venous and/or infectious componentLittle to no drainage may have ischemic component

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16Digital ulcer in diabetic with PAD, ischemic base, atrophic skinUlcer associated with brown recluse spider bite, skin necrosis, underlying abscessRadiographic / Imaging for infectionX-rays osteomyelitis (bone erosions, periostitis) soft tissue gasMRIUseful if X-rays not definitiveNuclear Medicine3 phase bone scan more sensitive than plain X-rays for osteomyelitis, less specificOften false positive with Charcot joint, Arthritis, fracture, recent injury, recent bone surgery (6 or more months)Labeled scan (Indium, Gadolinium, Ceretec) may be more specific

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Classifications of diabetic ulcersWagner most commonly used and recognized.Stage 0 - No active ulcer, but risk factors present (pre-ulcerative callous, history of foot ulcer, foot deformity)Stage 1 - Superficial ulcer , to subcutaneous fat.Stage 2 - Ulcer to tendon, ligament, joint capsule, or deep fascia, no major abscessStage 3 - Ulcer to bone (or deep abscess)Stage 4 - Ulceration with forefoot ischemia. Stage 5 - Ulceration with ischemia of entire foot.

University of Texas San AntonioOthers

18Basics of wound healing

General principles of good wound careKISS principle (Keep It Simple, Stupid)Be sure to not overlook the obviousEvaluate and treat infection if present fullyRemoval of nonviable and infected tissue when possibleIn osteomyelitis, all infected bone should be removed

See if the wound will rapidly respond to simple, basic treatments.If it isn t broken, dont fix it.Continue basic treatments and regular observation.

20Treatments / wound care

Traditional productsSaline, betadine, gauze, etc.

Pressure reliefBraces (e.g. Podus boots)PillowsAmbulatory bracing21Other wound care productsChemical debridersUnna boots, multi-layered compression wrapsLeg compression pumpsMay be helpful with venous ulcersDebriding / wound lavage instrumentsPulse lavage Ultrasonic and hydrosurgical debriders

22PAD treatmentsMedical treatment for PADPlavix inhibits platelet aggregation Pletal inhibits platelet aggregation and provides vasodilationContraindicated in CHF.Trental enhances platelet flexibility, full effects 90-120 days

Topical Nitroglycerin (nitroglycerin ointment, Nitrodur patches)Provideslocalized vasodilation - increases wound perfusion.Helpful particularly in cases where limb perfusion cannot be enhanced by vascular intervention.Have to be cautious of hypotension particularly in elderly and/or those with cardiac disease apply thin layer.

23Surgical procedures - traditional Incision and drainage / surgical debridementThe solution to pollution is dilution.Removal of infected / nonviable tissue.All infected bone in osteomyelitis should be removed.Amputation levelsBKA/ AKA goal is to avoidSymes, Choparts, Transmetatarsal, LisFrancsDigital partial or complete

Surgical Wound closure / coverageFlaps (Advancement, rotational)Skin GraftsOther complex wound

24Surgical procedures -Amputations

Considerations in amputation selection levelVascular supply- Is it adequate for healing?- Is the patient a candidate for revascularization?Consider how the limb and patient will functionNonambulatory patients may be better served with a more proximal amputation Patients with otherwise impaired isolated limb function need individualized consideration DropfootFlexion ContracturePreservation of as much of a functional limb as possible.- Decreased cardiac workloadPlan bone and soft tissue resection and closure carefully to prevent further problems

25Advanced treatments and products

26Newer wound dressingsAdvanced wound dressings more absorbent, hydrating, and/or antimicrobial than gauzeAlginates very absorbent (e.g. Fibracol)Hydrogels maintain optimal wound hydration, Silver antimicrobial vs. MRSA contamination / colonizationSilver alginates e.g. Acticoat rope Silver Hydrogels e.g. Silvasorb, Aquacel Ag Silver sheet dressings e.g. ActicoatHoney Collagen dressings (Promogran) release collagen into wound base which is helpful in wound healing.

27Topical - Growth Factors Stimulate the healing process Dermagraft Vicryl sheet with Fibroblasts

Apligraf similar product bilayered absorbable mesh with keratinocytes on one layer, fibroblasts on the other.

Regranex Topical gel with smaller amounts of growth factors.

Procuren - Older product

Future Stem cell-derived products, Additional bilayered skin equivalents28New surgical products - scaffoldsGraftJacket, AllodermFreeze-dried human dermis Provides a collagen scaffold for ingrowth of granulation tissueBrigido - Compared single application of GraftJacket to sharp debridement, weekly dressing changes - 85.7% healed with GraftJacket at 12 weeks vs. 28.6% healed at 12 weeks without. Integra dermal replacement, bilayered allows for ingrowth of new skinOasis Porcine intestinal subucosaPegasus (OrthoAdapt) equine pericardiumRejection a possibility

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SCAFFOLD CONCEPT HEALING TISSUE GROWS INTO THE GRAFT GRAFT REPLACED WITH PATIENTS OWN TISSUE OVER TIME

GraftJacket Sample caseInfected wound dehiscence ulcer 6 weeks s/p I & D, & IV antibioticsAfter debridement

GraftJacket applied in OR (Osteoset antibiotic beads and VAC also used.)31

GraftJacket Sample case1 week post-op Osteoset absorbable antibiotic beads also noted2 weeks post - op8 weeks post-opWound healed around 16 weeks post - op32Advanced treatments and productsNegative pressure therapy suction devicesEliminates wound exudateWaste products from tissue can be toxic to healingPrevents macerationCan reduce wound volume by suction effectEnhances capillary ingrowthDaily dressing changes not necessary 1-2 times a week.Classic article Morykwas and Argenta, 1997.Also frequently used with split-thickness skin grafts and freeze-dried dermis grafts to enhance adherence of the graft to the wound base.

33Business Template

3434Hyperbaric OxygenMechanisms of action: wound healing is enhanced by increased fibroblast proliferation, increased collagen production, increased capillary angiogenesis, and release of growth.

100% oxygen in a pressurized full-body treatment chamberUsually pressurization should be at least 1.4 atm abs (usually 2 2.5 atm abs)Can enhance wound healing, particularly in debilitated patientsEffects on the oxygen saturation of the blood may be more important that local effects on the wound.Useful in infections antimicrobial effects, particularly in anaerobic infections (bacteriostatic), osteomyelitis

35Advanced Treatments When to useIf the wound is not responding well to traditional careSheehan - 203 patients (prospective, randomized) studyMedian healing percentage at 4 weeks was 53%-If > 53% healed @ 4 weeks, then 58% chance of full wound healing at 12 weeks -If < 53% healed, then only 9% were healed at 12 weeks. Conclusion if not 53% healed at 4 weeks, then additional care needed.

Anticipated difficulty in healing / high complication potentialSize/ depthAnatomic Location Patient risk factors

Cost-Effectiveness Considerations:Is the potential cost of not doing something more aggressive going to be more expensive than the cost of the advanced therapy?

36Questions to ask when considering advanced and / or new treatmentsAre there other treatable reasons the ulcer is not healing?Infection adeqaute medical and surgical treatmentVascular supply is it adequate or can it be improved?Patient factors - (overall health, noncompliance, etc.)Pressure relief offload the wound site

Would additional consults be appropriate?

Is there adequate evidence based medicine that the treatment or product is effective, particularly for the situation?

37Selection of appropriate advanced therapy

How can the healing process be best enhanced for the ulcer?Applying medical expertise and judgment to each situation Medicine is often more an art than a science. Know what each product can do particular indications and benefits of each device or treatment.

Are there any reasons why advanced treatments cannot be used in the situation?38

The Healed Diabetic Foot What next? Crane M, Branch P. Clin Pod Med Surg. v. 15, n 1, Jan 1998, p. 155-74.39Prevention of diabetic foot ulcersEducation risk of foot ulcers and importance of early treatment.Patients should examine their feet daily

Annual foot exam - more frequent if high ulcer risk (previous ulcer,neuropathic, PAD).- Diabetic neurologic evaluation (PQRI #G8404)- Evaluation for appropriate diabetic foot wear (PQRI #G8410)Recommended by the American Diabetes Association as well as annual eye exam.

relative risk for ulceration40Diabetic Nail and Callous carePrevention / early treatment of ingrown nails and pre-ulcerative callousesPrevention of patients cutting the skin when cutting their own nails

41PAD Follow-upFollow-up for progressive PAD Clinical examArterial ultrasoundEnsure maintenance of adequate vascular status.Particularly important after vascular intervention (stenting, bypass, etc.) to examine for patency of the treated arteries.

42Protective devices for foot ulcer preventionCustom BracesAFO (Ankle Foot Orthosis)Dropfoot bracesRigid AFO for severe flatfoot or other deformitiesPatellar Tendon brace shifts some pressure to patellar tendon

Protective shoesExtra Depth shoes with custom molded protective foam insoles to balance pressureCustom Molded shoes made from a plaster mold of the patients footCommonly used in severe foot deformities e.g. Charcot Rocker-bottom foot43Diabetic shoes - CharacteristicsMedicare Therapeutic Shoe Bill covers protective shoes for diabetics annually.Also covered by many private insurers and Medicaid providersExtra-depth shoes vs. True Custom-molded shoesDocumented successCDC has proven that they reduce the incidence of foot amputationIn patients with a history of foot ulcers, 80% without diabetic shoes, 20% with properly fitted protective diabetic shoes.At minimum are cost-neutralShould be professionally fitted by individuals with proper training (DPM, C Ped, CO) 44Elective surgical proceduresSurgical interventionFor pain and/or ulcer prevention from foot deformities Conservative measures should be exhausted firstExample elective minor proceduresHammertoe and Bunion correction45

Elective surgical proceduresTendon lengthening or tenotomy procedures for contractures Exostectomy procedures (reduction of bony prominences)Reconstructive surgery (e.g. Charcot joint reconstruction / realignment)Should be only as a last resort and undertaken with great caution and careful patient selection.

Patient MUST be thoroughly evaluated before surgery for adequate circulation and other risk factors for wound healing problems.46

Those who suffer losses due to diabetes are not just statistics on a chart. They are people whose talents and wisdom are needed and whose problems deserve our unified efforts. Together we can make life more just and more joyful for generations to come D Satcher47

THANK YOUJ. Palmer Branch, DPM DrCuboid@aol.com Comprehensive Foot & Ankle, LLCwww.comprehensivefootandankle.net Lilburn, GA (770-921-8800); Cumming, GA (770-886-6833)

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