Advances in healing of diabetic ulcersJ. Palmer Branch, DPMComprehensive Foot and Ankle, LLC

www.comprehensivefootandankle.net

DrCuboid@aol.com

Lilburn, GA (770-921-8800) Cumming, GA (770-886-6833)1

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Overview – 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?

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Overview – Additional comments

• Recent 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

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Demographics - USA

•In the US Diabetes has reached epidemic proportions

–Over 16 million people diagnosed with diabetes

–8 million estimated undiagnosed•15% of all diabetics will have a foot ulcer

at some point in their lives•PAD risk 2-6 times greater in diabetics.• 6% of all diabetics undergo amputation• 75% of all diabetic amputations are

preventable•Increased 5 year mortality rate (18 to

55% higher in ischemic ulcers)

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Costs of diabetic limb amputation

• Costs – 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 nursing– Surgical procedures - Skilled nursing facilities– Prosthetic limbs - Recurrent problems

• Other cost factors– Lost wages – short-term and long-term– Lost income tax revenues to federal / state / local government– Dependence on public assistance – Medicaid, Social Security– Depression, despondency, disruption of family.

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Cardiac disease and foot ulcers• Increased 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?

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Risk factors for impaired wound healing

• PAD (peripheral arterial disease) – 2-6 times more prevalent in DM.

• Neuropathy – lack of protective sensation, motor imbalance

• Immunocompromised status

• Structural problems – focal pressure sites– Contractures of toes, bunion deformities– Equinus contractures – tightness of the Achilles tendon– Charcot joint / arthropathy

• Other health factors

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PAD 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.

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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)hyperglycemia

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Causes of ulcers - Neurologic

• Loss of protective sensation (LOPS)

• Motor imbalances – Dropfoot and other motor function alteration

• Autonomic neuropathy

• Charcot Arthropathy / Charcot Joint

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Venous Ulcers

• Venous

- 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

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Evaluation of the diabetic ulcer

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Evaluation of the diabetic ulcer• Size – length, width and depth

• Probe to bone or visible bone – clinical osteomyelitis– Grayson - 75 patients, 76 ulcers

• Sensitivity of 66% for osteomyelitis• Specificity of 85%• Positive predictive value of 89%• Negative predictive value of 56%.

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Evaluation of the diabetic ulcer

• Cellulitis – not always present in patients with PAD or immune compromise

• Wound base quality – eschar, granular, fibro-fatty

• Malodor

• Surrounding skin and wound margins

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Evaluation of the diabetic ulcer

• Location

• Abscess – visible or palpable– tissue crepidus

• Drainage type– Purulent vs. serous – Amount – Healthy granular tissue normally has mild to moderate

drainage.• Heavy drainage – may have venous and/or infectious

component• Little to no drainage – may have ischemic component

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Digital ulcer in diabetic with PAD, ischemic base, atrophic skin

Ulcer associated with brown recluse spider bite, skin necrosis, underlying abscess

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Radiographic / Imaging for infection

• X-rays – osteomyelitis (bone erosions, periostitis) – soft tissue gas

• MRI– Useful if X-rays not definitive

• Nuclear Medicine– 3 phase bone scan – more sensitive than plain X-rays for

osteomyelitis, less specific• Often 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 ulcers

Wagner – 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 abscess– Stage 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 Antonio• Others

Basics of wound healing

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General principles of good wound care

• KISS principle (Keep It Simple, Stupid)– Be sure to not overlook the obvious– Evaluate and treat infection if present fully– Removal of nonviable and infected tissue when possible– In osteomyelitis, all infected bone should be removed

• See if the wound will rapidly respond to simple, basic treatments.– If it isn’ t broken, don’t fix it.– Continue basic treatments and regular observation.

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Treatments / wound care

• Traditional products

Saline, betadine, gauze, etc.

• Pressure relief– Braces (e.g. Podus boots)– Pillows– Ambulatory bracing

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Other wound care products

• Chemical debriders• Unna boots, multi-layered compression wraps• Leg compression pumps

– May be helpful with venous ulcers• Debriding / wound lavage instruments

– Pulse lavage – Ultrasonic and hydrosurgical debriders

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PAD – treatments

• Medical treatment for PAD– Plavix – inhibits platelet aggregation – Pletal – inhibits platelet aggregation and provides

vasodilation• Contraindicated 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.

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Surgical procedures - traditional

• Incision and drainage / surgical debridement– “The solution to pollution is dilution”.– Removal of infected / nonviable tissue.– All infected bone in osteomyelitis should be removed.

• Amputation levels– BKA/ AKA – goal is to avoid– Symes, Chopart’s, Transmetatarsal, LisFranc’s– Digital – partial or complete

• Surgical Wound closure / coverage– Flaps (Advancement, rotational)– Skin Grafts– Other complex wound

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Surgical procedures -Amputations

• Considerations in amputation selection level– Vascular supply

• - Is it adequate for healing?• - Is the patient a candidate for revascularization?

– Consider how the limb and patient will function• Nonambulatory patients may be better served with a more proximal

amputation • Patients with otherwise impaired isolated limb function need individualized

consideration

Dropfoot Flexion Contracture

– Preservation of as much of a functional limb as possible.- Decreased cardiac workload

– Plan bone and soft tissue resection and closure carefully to prevent further problems

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Advanced treatments and products

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Newer wound dressings

Advanced wound dressings – more absorbent, hydrating, and/or antimicrobial than gauze– Alginates – very absorbent (e.g. Fibracol)– Hydrogels – maintain optimal wound hydration, – Silver – antimicrobial vs. MRSA contamination / colonization

• Silver alginates – e.g. Acticoat rope • Silver Hydrogels – e.g. Silvasorb, Aquacel Ag • Silver sheet dressings – e.g. Acticoat

– Honey – Collagen dressings (Promogran) – release collagen into wound

base which is helpful in wound healing.

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Topical - 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 equivalents

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New surgical products - scaffolds• GraftJacket, Alloderm

- Freeze-dried human dermis - Provides a collagen scaffold for ingrowth of granulation tissue– Brigido - 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 skin

• Oasis – Porcine intestinal subucosa• Pegasus (OrthoAdapt) – equine pericardium

• Rejection a possibility 

SCAFFOLD CONCEPT – HEALING TISSUE GROWS INTO THE GRAFT – GRAFT REPLACED WITH PATIENT’S OWN TISSUE OVER TIME

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GraftJacket – Sample case

Infected wound dehiscence ulcer– 6 weeks s/p I & D, & IV antibiotics

After debridement

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

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GraftJacket – Sample case

1 week post-op Osteoset absorbable antibiotic beads also noted

2 weeks post - op

8 weeks post-op Wound healed around 16 weeks post - op

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Advanced treatments and products

• Negative pressure therapy – suction devices– Eliminates wound exudate

- Waste products from tissue can be toxic to healing- Prevents maceration

– Can reduce wound volume by suction effect– Enhances capillary ingrowth– Daily 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.

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Business Template

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Hyperbaric Oxygen

– Mechanisms 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 chamber• Usually pressurization should be at least 1.4 atm abs (usually 2

– 2.5 atm abs)– Can enhance wound healing, particularly in debilitated patients– Effects 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 

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Advanced Treatments – When to use•If the wound is not responding well to traditional care

Sheehan - 203 patients (prospective, randomized) study

Median 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 potential

Size/ depth Anatomic 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?

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Questions to ask when considering advanced and / or new treatments

•Are there other treatable reasons the ulcer is not healing?

– Infection – adeqaute medical and surgical treatment– Vascular 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?

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Selection 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?

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The Healed Diabetic Foot – What next?

Crane M, Branch P. Clin Pod Med Surg. v. 15, n 1, Jan 1998, p. 155-74.

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Prevention of diabetic foot ulcers• Education

– 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 ulceration

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Diabetic Nail and Callous care

• Prevention / early treatment of ingrown nails and pre-ulcerative callouses

• Prevention of patients cutting the skin when cutting their own nails

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PAD – Follow-up

• Follow-up for progressive PAD – Clinical exam– Arterial ultrasound

• Ensure maintenance of adequate vascular status.

• Particularly important after vascular intervention (stenting, bypass, etc.) to examine for patency of the treated arteries.

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Protective devices for foot ulcer prevention

• Custom Braces– AFO (Ankle – Foot Orthosis)

• Dropfoot braces• Rigid AFO for severe flatfoot or other deformities

– Patellar Tendon brace – shifts some pressure to patellar tendon

• Protective shoes– Extra Depth shoes with custom molded protective foam insoles

to balance pressure– Custom Molded shoes – made from a plaster mold of the

patient’s foot

Commonly used in severe foot deformities – e.g. Charcot Rocker- bottom foot

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Diabetic shoes - Characteristics• Medicare Therapeutic Shoe Bill covers protective shoes for

diabetics annually.• Also covered by many private insurers and Medicaid providers• Extra-depth shoes vs. True Custom-molded shoes• Documented success

– CDC has proven that they reduce the incidence of foot amputation• In patients with a history of foot ulcers, 80% without diabetic

shoes, 20% with properly fitted protective diabetic shoes.– At minimum are cost-neutral

• Should be professionally fitted by individuals with proper training– (DPM, C Ped, CO)

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Elective surgical procedures• Surgical intervention

– For pain and/or ulcer prevention from foot deformities – Conservative measures should be exhausted first

• Example elective minor procedures– Hammertoe and Bunion correction

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Elective surgical procedures• Tendon 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.

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“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 Satcher

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THANK YOU

J. 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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