Diabetic Foot Ulcers Treatment & Management

Updated: Jan 22, 2020
  • Author: Vincent Lopez Rowe, MD; Chief Editor: Romesh Khardori, MD, PhD, FACP  more...
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Treatment

Approach Considerations

The management of diabetic foot ulcers requires offloading the wound by using appropriate therapeutic footwear, [8, 9] daily saline or similar dressings to provide a moist wound environment, [10] debridement when necessary, antibiotic therapy if osteomyelitis or cellulitis is present, [11, 12] optimal control of blood glucose, and evaluation and correction of peripheral arterial insufficiency. [33]

Wound coverage by cultured human cells [31, 34] or heterogeneic dressings/grafts, application of recombinant growth factors, [35, 36, 37, 38] and hyperbaric oxygen treatments also may be beneficial at times, but only if arterial insufficiency is not present.

Physicians of diabetic patients with ulcers must decide between the sometimes conflicting options of (1) performing invasive procedures (eg, angiography, bypass surgery) for limb salvage and (2) avoiding the risks of unnecessarily aggressive management in these patients, who may have significant cardiac risk. In general, the greatest legal risks are associated with delay in diagnosis of ischemia associated with diabetic ulceration, failure to aggressively debride and treat infection, and failure to treat the wound carefully.

If a patient presents with a new diabetic foot ulcer, he or she should receive care from physicians, surgeons, podiatrists, and pedorthotists who have an active interest in this complex problem.

IWGDF guidelines

The aforementioned IWGDF practical guidelines state the following with regard to pressure offloading in ulcer treatment [27] :

  • For patients with a neuropathic plantar ulcer, a nonremovable knee-high offloading device—ie, either a total contact cast (TCC) or a removable walker that is rendered irremovable by the provider who fits the device—is the preferred offloading treatment
  • In patients who cannot tolerate a nonremovable, knee-high offloading device, or if such a device is contraindicated, a removable version can be considered; should a removable device be contraindicated or if it cannot be tolerated, an ankle-high offloading device can be considered; patients must be educated with regard to the benefits of adherence to removable device use
  • In the absence of other forms of biomechanical relief, felted foam, in combination with appropriate footwear, can be considered
  • While offloading remains important in the presence of infection or ischemia, greater caution is necessary
  • Nonplantar foot ulcers, depending on their type and location, should be addressed with a removable, ankle-high offloading device, footwear modifications, toe spacers, or orthoses

With regard to restoration of tissue perfusion, the practical guidelines state the following [27] :

  • When ankle pressure is below 50 mmHg or the ankle brachial index (ABI) is less than 0.5, urgent vascular imaging and, in the presence of appropriate findings, revascularization, should be considered; revascularization should also be considered if the toe pressure is below 30 mmHg or the transcutaneous pressure of oxygen (TcpO 2) is less than 25 mmHg; however, revascularization may be considered at higher pressures should extensive tissue loss or infection occur
  • If optimal treatment does not result in ulcerative healing signs within 6 weeks, revascularization should be considered, regardless of the outcomes of the above-mentioned vascular tests
  • If an above-the-ankle amputation is being contemplated, revascularization should first be considered as an option
  • Revascularization should be avoided in patients with an unfavorable risk-benefit ratio
  • Individual factors (eg, morphologic distribution of peripheral artery disease, autogenous vein availability, patient comorbidities) and local operator expertise should be considered when selecting a revascularization technique
  • Following revascularization, perfusion should be objectively measured to assess the procedure’s effectiveness
  • Pharmacologic treatments have not been proven to benefit perfusion
  • Smoking cessation, hypertension and dyslipidemia control, and antiplatelet drug use, as the means to reduce cardiovascular risk, should be emphasized

With regard to treatment of infection, the practical guidelines state the following [27] :

  • For a superficial ulcer with limited soft tissue (mild) infection - The ulcer should be cleansed and all necrotic tissue and surrounding callus should be debrided; start empiric oral antibiotic therapy directed against Staphylococcus aureus and streptococci (unless there are indications that alternative or additional likely pathogens exist)
  • For deep or extensive (potentially limb-threatening) infection (moderate or severe infection) - The need for surgical intervention to remove necrotic tissue, including infected bone, should be urgently evaluated, and compartment pressure should be released or abscesses drained; assess for peripheral artery disease (with urgent treatment, including revascularization, to be considered if such disease is present); empiric, parenteral, broad-spectrum antibiotic therapy aimed at common gram-positive and gram-negative bacteria, including obligate anaerobes, should be initiated; the clinical response to empirical therapy, along with culture and sensitivity results, should be used to adjust (constrain and target, if possible) the antibiotic regimen

With regard to local ulcer care, the practical guidelines recommend the following [27] :

  • The ulcer must be inspected regularly by a trained health-care provider, with the severity of the ulcer, the underlying pathology, the presence of infection, the amount of exudation, and wound treatment provided determining the frequency of examination
  • Ulcer débridement and removal of the surrounding callus (preferably with sharp surgical instruments) should be carried out, with the procedure repeated as necessary
  • Selected dressings should control excess exudation and keep the environment moist
  • Foot soaking may cause skin maceration and so should not be employed in treatment
  • Negative pressure should be considered as an aid to healing postoperative wounds
  • If noninfected ulcers do not heal after 4-6 weeks of optimal clinical care, one of the following adjunctive treatments should be considered - If severe ischemia is not present in a neuro-ischemic ulcer, a sucrose octasulfate–impregnated dressing; if moderate ischemia is either present or absent, a multi-layered patch of autologous leucocytes, platelets, and fibrin; also in the presence of absence of moderate ischemia, placental membrane allografts; in ischemic ulcers in which revascularization has not led to healing, adjunctive treatment with systemic oxygen therapy
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Management of Systemic and Local Factors

Treatment of diabetic foot ulcers requires management of a number of systemic and local factors. [39, 40, 41, 42]

Precise diabetic control is, of course, vital, not only in achieving resolution of the current wound, but also in minimizing the risk of recurrence. Management of contributing systemic factors, such as hypertension, hyperlipidemia, atherosclerotic heart disease, obesity, or renal insufficiency, is crucial. [43, 44] Management of arterial insufficiency, treatment of infection with appropriate antibiotics, offloading the area of the ulcer, and wound care are also essential.

For more information, see Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2.

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Wound and Foot Care

The basic principle of topical wound management is to provide a moist, but not wet, wound bed. [10, 45]

For more information, see Diabetic Foot Infections.

Wound coverage

After debridement, apply a moist sodium chloride dressing or isotonic sodium chloride gel (eg, Normlgel, IntraSite gel) or a hydroactive paste (eg, Duoderm). Optimal wound coverage requires wet-to-damp dressings, which support autolytic debridement, absorb exudate, and protect surrounding healthy skin. A polyvinyl film dressing (eg, OpSite, Tegaderm) that is semipermeable to oxygen and moisture and impermeable to bacteria is a good choice for wounds that are neither very dry nor highly exudative. Wound coverage recommendations for some other wound conditions are as follows (see the Table, below) [46] :

  • Dry wounds: Hydrocolloid dressings, such as DuoDERM or IntraSite Hydrocolloid, are impermeable to oxygen, moisture, and bacteria; maintain a moist environment; and support autolytic debridement. They are a good choice for relatively desiccated wounds.

  • Exudative wounds: Absorptive dressings, such as calcium alginates (eg, Kaltostat, Curasorb), are highly absorptive and are appropriate for exudative wounds. Alginates are available in a rope form, which is useful for packing deep wounds.

  • Very exudative wounds: Impregnated gauze dressings (eg, Mesalt) or hydrofiber dressings (eg, Aquacel, Aquacel-Ag) are useful for extremely exudative wounds. In these cases, twice-daily dressing changes may be needed.

  • Infected wounds: For infected superficial wounds, use Silvadene (silver sulfadiazine) if the patient is not allergic to sulfa drugs; if a sulfa allergy exists, either bacitracin-zinc or Neosporin ointment is a good alternative. Where heavy bacterial contamination of deeper wounds exists, irrigation using one-fourth strength Dakin solution and 0.25% acetic acid may be useful for a brief period of time; a hydrofiber-silver dressing (Aquacel-Ag) can help control wounds that are both exudative and potentially colonized.

  • Wounds covered by dry eschar: In this case, simply protecting the wound until the eschar dries and separates may be the best management. Occasionally, painting the eschar with povidone iodine (Betadine) is beneficial to maintain sterility while eschar separation occurs; an uninfected dry heel ulcer in a well-perfused foot is perhaps best managed in this fashion.

  • Areas that are difficult to bandage: Bandaging a challenging anatomical area, such as around a heel ulcer, requires a highly conformable dressing, such as an extra thin hydrocolloid; securing a dressing in a highly moist challenging site, such as around a sacrococcygeal ulcer, requires a conformable and highly adherent dressing, such as a wafer hydrocolloid.

  • Fragile periwound skin: Hydrogel sheets and nonadhesive forms are useful for securing a wound dressing when the surrounding skin is fragile.

Other topical preparations that occasionally may be useful in the management of diabetic foot ulcers are as follows:

  • Platelet-derived growth factors (PDGF): Topically applied PDGF has a modestly beneficial effect in promoting wound healing. Becaplermin gel 0.01% (Regranex), a recombinant human PDGF that is produced through genetic engineering is approved by the US Food and Drug Administration (FDA) to promote healing of diabetic foot ulcers. [36] Regranex is meant for a healthy, granulating wound, not one with a necrotic wound base, and is contraindicated with known skin cancers at the site of application.

  • Enzymatic debridement: Collagen comprises a significant fraction of the necrotic soft tissues in chronic wounds; the enzyme collagenase, derived from fermentation of Clostridium histolyticum, helps remove nonviable tissue from the surface of wounds. However, it is not a substitute for an initial surgical excision of a grossly necrotic wound.

  • Miscellaneous topical agents: Various other topical agents that have been used for wound management include sugar, antacids, and vitamin A and D ointment.

Cytotoxic agents, such as hydrogen peroxide, povidone iodine, acetic acid, and Dakin solution (sodium hypochlorite), should be avoided, except as noted above under infected wounds.

Table. Characteristics and Uses of Wound Dressing Materials (Open Table in a new window)

Category

Examples

Description

Applications

Alginate

AlgiSite

Comfeel

Curasorb

Kaltogel

Kaltostat

Sorbsan

Tegagel

This seaweed extract contains guluronic and mannuronic acids that provide tensile strength and calcium and sodium alginates, which confer an absorptive capacity. Some of these can leave fibers in the wound if they are not thoroughly irrigated. These are secured with secondary coverage.

These are highly absorbent and useful for wounds having copious exudate. Alginate rope is particularly useful to pack exudative wound cavities or sinus tracts.

Hydrofiber

Aquacel

Aquacel-Ag

Versiva

An absorptive textile fiber pad, also available as a ribbon for packing of deep wounds. This material is covered with a secondary dressing. The hydrofiber combines with wound exudate to produce a hydrophilic gel. Aquacel-Ag contains 1.2% ionic silver that has strong antimicrobial properties against many organisms, including methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus.

These are absorbent dressings used for exudative wounds.

Debriding agents

Hypergel (hypertonic saline gel)

Santyl (collagenase)

Accuzyme (papain urea)

Various products provide some degree of chemical or enzymatic debridement.

These are useful for necrotic wounds as an adjunct to surgical debridement.

Foam

LYOfoam

Spyrosorb

Allevyn

Polyurethane foam has some absorptive capacity.

These are useful for cleaning granulating wounds having minimal exudate.

Hydrocolloid

Aquacel

CombiDERM

Comfeel

Duoderm CGF Extra Thin

Granuflex

Tegasorb

These are made of microgranular suspension of natural or synthetic polymers, such as gelatin or pectin, in an adhesive matrix. The granules change from a semihydrated state to a gel as the wound exudate is absorbed.

They are useful for dry necrotic wounds, wounds having minimal exudate, and clean granulating wounds.

Hydrogel

Aquasorb

Duoderm

IntraSite Gel

Granugel

Normlgel

Nu-Gel

Purilon Gel

(KY jelly)

These are water-based or glycerin-based semipermeable hydrophilic polymers; cooling properties may decrease wound pain. These gels can lose or absorb water depending upon the state of hydration of the wound. They are secured with secondary covering.

These are useful for dry, sloughy, necrotic wounds (eschar).

Low-adherence dressing

Mepore

Skintact

Release

These are various materials designed to remove easily without damaging underlying skin.

These are useful for acute minor wounds, such as skin tears, or as a final dressing for chronic wounds that have nearly healed.

Transparent film

OpSite

Skintact

Release

Tegaderm

Bioclusive

These are highly conformable acrylic adhesive film having no absorptive capacity and little hydrating ability, and they may be vapor permeable or perforated.

These are useful for clean dry wounds having minimal exudate, and they also are used to secure an underlying absorptive material. They are used for protection of high-friction areas and areas that are difficult to bandage such as heels (also used to secure IV catheters).

For more information, see Diabetic Foot Infections.

Vacuum-assisted closure

Clean but nonhealing deep cavity wounds may respond to repeated treatments by application of negative pressure under an occlusive wound dressing (vacuum-assisted closure [VAC]). [47]

Hydrotherapy

Intractable, infected, cavity wounds sometimes improve with hydrotherapy using saline pulse lavage under pressure (PulsEvac).

Extracorporeal shock-wave therapy

Two multicenter, randomized, sham-controlled, double-blinded, phase III clinical trials by Snyder et al indicated that extracorporeal shock-wave therapy (ESWT) can effectively treat neuropathic diabetic foot ulcers that fail to heal with standard therapy alone. At 24 weeks, in patients with diabetic foot ulcers that had not been reduced by 50% or greater over the course of 2 weeks’ standard treatment, complete healing occurred in 37.8% of patients treated with ESWT and standard care, compared with 26.2% of patients treated with sham therapy and standard care. [48]

Treatment of Charcot foot

Charcot foot is treated initially with immobilization using special shoes or braces but eventually may require podiatric surgery such as ostectomy and arthrodesis.

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Surgical Care

All patients harboring diabetic foot ulcers should be evaluated by a qualified vascular surgeon and/or podiatric surgeon who will consider debridement, revisional surgery on bony architecture, vascular reconstruction, and options for soft tissue coverage.

For more information, see Perioperative Management of the Diabetic Patient.

Debridement

Surgical management is indicated for debridement of nonviable and infected tissue from the ulceration, removal of excess callus, curettage of underlying osteomyelitic bone, skin grafting, and revascularization. The wound usually requires an initial surgical debridement and probing to determine the depth and involvement of bone or joint structures. Visible or palpable bone implies an 85% chance of osteomyelitis.

Revisional surgery

Revisional surgery for bony architecture may be required to remove pressure points. [49] Such intervention includes resection of metatarsal heads or ostectomy. [50]

Vascular reconstruction

In general, the indications for vascular surgery in the presence of a reconstructible arterial lesion include intractable pain at rest or at night, intractable foot ulcers, and impending or existing gangrene. [15, 51, 52] Intermittent claudication alone is only infrequently disabling and intractable enough to warrant bypass surgery. Physicians must specifically ask for symptoms suggestive of intermittent claudication, such as pain in the buttocks and thighs while walking and abatement of pain when at rest.

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Options for Soft Tissue Coverage of the Clean but Nonhealing Wound

Once a wound has reached a steady clean state, a decision has to be made about allowing healing by natural processes or expediting healing by a surgical procedure. Clinical experience and observation of the healing progress in each case dictate the appropriate management. Surgical options include skin grafting, application of bioengineered skin substitutes, and flap closures. [53]

Skin grafts

The autologous skin graft is the criterion standard for viable coverage of the partial thickness wound. The graft can be harvested under local anesthesia as an outpatient procedure. Meshing the graft allows wider coverage and promotes drainage of serum and blood.

A cadaveric skin allograft is a useful covering for relatively deep wounds following surgical excision when the wound bed does not appear appropriate for application of an autologous skin graft. The allograft is, of course, only a temporary solution.

Tissue-cultured skin substitutes

Dermagraft (Smith & Nephew) is a cryopreserved human fibroblast–derived dermal substitute produced by seeding neonatal foreskin fibroblasts onto a bioabsorbable polyglactin mesh scaffold. Dermagraft is useful for managing full-thickness chronic diabetic foot ulcers. It is not appropriate for infected ulcers, those that involve bone or tendon, or those that have sinus tracts.

A multicenter study of 314 patients demonstrated significantly better 12-week healing rates with Dermagraft (30%) versus controls (17%). Allergic reactions to its bovine protein component have been reported.

Apligraf (Organogenesis) is a living, bilayered human skin substitute. [54, 34] It is not appropriate for infected ulcers, those that involve tendon or bone, or those that have sinus tracts. Allergic reactions to the agarose shipping medium or its bovine collagen component have been reported.

A prospective observational study by Hwang et al indicated that treatment with allogeneic keratinocyte dressings is effective in patients with chronic, intractable diabetic foot ulcers. Of the 71 patients in the study, all of whom underwent weekly keratinocyte therapy, 56 (78.9%) experienced complete wound healing, including 46 (64.8%) in whom complete healing occurred within an average of 6.1 weeks. [55]

The use of bioengineered skin substitutes has been questioned because the mechanism of action is not clear, the efficacy is questionable, and the cost is high.

Xenograft

Oasis (Healthpoint, Ltd) is a xenogeneic, acellular collagen matrix derived from porcine small intestinal submucosa in a way that allows an extracellular matrix and natural growth factors to remain intact. This provides a scaffold for inducing wound healing. Do not use this for patients with allergies to porcine materials.

Surgical wound closure

Delayed primary closure of a chronic wound requires well-vascularized clean tissues and tension-free apposition; it usually requires undermining and mobilization of adjacent tissue planes by creation of skin flaps or myocutaneous flaps. [56]

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Hyperbaric Oxygen Treatment

Hyperbaric oxygen therapy is used rarely and is certainly not a substitute for revascularization. [57] In the presence of an intractable wound and associated noncorrectible ischemic arterial disease, hyperbaric oxygen therapy may be beneficial (in selected cases). [58] Löndahl et al found that 40 hyperbaric oxygen treatments (85 min daily, 5 d/wk for 8 wk) resulted in complete healing of chronic diabetic foot ulcers in 52% of patients in the treatment group. Among patients in the placebo group, 29% had complete healing at 1-year follow-up. [59] Although data are equivocal on the impact of hyperbaric oxygen therapy in ischemic and pressure ulcers, positive benefits have been documented in diabetic chronic foot ulcers. [60, 61]

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Dietary Chages

The recommended diet is diabetic and low in saturated fat.

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Restriction of Activity

Offloading of the ulcerated area is imperative. This may require bed rest acutely. Custom footwear or custom clamshell orthosis (for severe deformities) or total contact casting (a fiberglass shell with a walking bar on the bottom) are required for patients who are ambulatory.

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Measures for Prevention of Diabetic Ulcers

The risk of ulceration and limb amputation in people with diabetes can be improved by routine preventive podiatric care, appropriate shoes, and patient education. [62] Diabetic clinics should screen all patients for altered sensation and peripheral vascular disease. [38] Of diabetic foot ulcers, 85% are estimated to be preventable with appropriate preventive medicine, including the following:

  • Daily foot inspection

  • Gentle soap and water cleansing

  • Application of skin moisturizer

  • Inspection of the shoes to ensure good support and fit: Medicare covers custom shoes with appropriate physician documentation confirming that the patient is at risk for ulceration.

  • Minor wounds require prompt medical evaluation and treatment.

  • Prophylactic podiatric surgery to correct high-risk foot deformities may be indicated.

  • Avoid hot soaks, heating pads, and irritating topical agents.

A literature review by Matos et al suggested that exercise and physical activity are effective against the complications of diabetic foot. The investigators found that patients involved in physical activity and exercise had a lower annual incidence of ulcers than other patients in the study (0.02 vs 0.12, respectively). Moreover, nerve velocity conduction, peripheral sensory function, and foot peak pressure distribution significantly improved in the physical activity/exercise group. [63]

Glycemic control

The Diabetes Control and Complications Trial, performed by the Diabetes Control and Complications Trial ResearchGroup,studiedthe effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus (1993). [64] This trial found that uncontrolled hyperglycemia correlates with the onset of diabetic microvascular complications and that good glycemic control can reduce or even prevent the complications of diabetes, including nephropathy, neuropathy, and retinopathy.

Cigarette smoking should be stopped, and hypertension and hyperlipidemia should be controlled.

To see complete information on the conditions below, please go to the main article by clicking on the title:

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Consultations

Any of the following evaluations may prove productive:

  • Endocrinologist

  • Cardiologist

  • Nephrologist

  • Infectious diseases specialist

  • Vascular surgeon

  • Podiatrist

  • Orthopedic specialist

  • Plastic surgeon

  • Wound care specialist

  • Nutritionist

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Long-Term Monitoring

For the most part, diabetic ulcers are managed in the outpatient setting, with brief hospital stays often occurring for initial evaluation and debridement, subsequent vascular procedures, and, possibly, flap or skin graft wound management.

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