Standard, Appropriate, and Advanced Care and
Medical-Legal Considerations: Part One—Diabetic Foot Ulcerations (B)

This is "B", which is a continuation of the article "Standard, Appropriate, and Advanced Care and Medical-Legal Considerations:Part One—Diabetic Foot Ulcerations (A)." Dressings Hundreds of dressings are currently on the market with more appearing each year.[48] Rather than provide an extensive discussion on available dressings, the basic concepts behind appropriate choice are presented. Extensive literature supports the benefits of moist wound healing.[49–56] Wounds should be dressed with materials that offer protection from outside contaminants, prevent wound desiccation, and provide an environment conducive to wound closure. The degree of moisture in a wound needs to be considered when treating the diabetic ulcer. Cellular immune response adequately addresses increased bacterial proliferation in a moist environment. Patients with compromised cellular immune responses may not be able to address high levels of bacterial proliferation in a highly exudative environment. Hutchinson, et al.,[57] studied the incidence of infection under occlusion and found it to be four times more likely to occur under dry gauze than under occlusion. This study did not, however, contain a large population of plantar, neuropathic, diabetic foot ulcers. Allowing prolonged pooling of exudate in a diabetic foot ulcer may be a potentially dangerous situation on a diabetic patient. Excessive moisture also contributes to maceration, which decreases tensile strength and, combined with pressure, shear, or friction, may lead to further wound deterioration. A simple rule may be followed when selecting the appropriate dressing for diabetic plantar foot ulcers. High levels of exudate warrant the choice of a moisture-absorbing material, which may include alginates, foams, collagen-alginate combinations, carboxymethylcellulose materials, or gauze. Low exudate and desiccated wounds respond well to hydrogels. Occlusive hydrocolloids are not recommended over highly exuding wounds in weight-bearing areas. The dressing needs to meet the need of the wound environment and should be changed as the status of the wound evolves. Diabetic ulcers require close evaluation. Dressing changes on moderate to heavily draining wounds are best performed on a daily basis or, at most, every two days on low-risk patients. Standard dressing care for the treatment of diabetic foot ulcers in the US is still the use of wet-to-dry or wet-to-moist saline gauze dressings. While gauze dressings are appropriate when twice- or three-times-daily dressing changes are required, care must be taken to prevent strikethrough of bacteria. Gauze does not offer an effective barrier to external contaminants and bacteria. Advanced dressings are available that are more appropriate for diabetic foot ulcers than gauze. Additional dressing choices include hydrogels, foams, calcium alginates, collagen alginates, and absorbent polymers. Choice of dressing depends on the depth, location, wound characteristics, bacterial burden, and treatment goal. The ideal dressing for the diabetic foot ulcer should prevent tissue desiccation, absorb excess fluid, and protect the wound from external contamination. Aggressive adhesives and completely occlusive dressings need to be avoided, particularly on weight-bearing surfaces or in areas of repetitive trauma. Foam dressings and alginates are effective for absorbing fluid, while hydrogels may be used on desiccated or low exudate wounds. The clinician must be aware that dressings are constantly evolving and require the healthcare provider to be informed of their indications and contraindications. Dressings are designed to address the wound environment and are not a substitute for offloading devices or infection and diabetes control. Advanced Care: New Technology Dressings may provide an environment conducive to healing. New biologic products and drugs directly interact with the wound environment to manipulate and direct activity at a cellular level. Currently, at least two skin equivalents are being used in the treatment of diabetic foot ulcers. Growth factors are also being carefully studied in many different wound environments. Skin replacements. Cultured human keratinocytes have been developed and used in the past. They are of limited benefit on full-thickness defects and have not been shown to be of benefit in the treatment of diabetic foot ulcers. Dermagraft® (Smith & Nephew Inc., Largo, Florida) is a semisynthetic material composed of human neonatal dermal fibroblasts cultured onto a bioabsorbable mesh. The metabolically active cells are responsible for the secretion of human dermal collagen, growth factors, and other proteins, which may contribute to wound closure. Dermagraft is FDA approved for use in the treatment of diabetic foot ulcers.[58–61] Apligraf® (Novartis Pharmaceuticals Inc., East Hanover, New Jersey) is a bilayered, allogeneic skin equivalent with a fully differentiated epidermis and a dermis. The dermis consists of bovine collagen containing human fibroblasts derived from human foreskins, while the epidermis is derived from keratinocytes also attained from infant foreskins. Apligraf is currently indicated for the treatment of venous ulcers and diabetic foot ulcers.[62–64] Growth factors. Prior to the introduction of Regranex® (becaplermin, Ortho-McNeil Pharmaceuticals, Inc., Raritan, New Jersey), the only available growth factor was an autologous, unregulated product called Procuren® (Curative Health Services, Hauppauge, New York).[65,66] While one study suggests a benefit to the use of autologous factors, an additional study indicates no difference between treatment with autologous factors and placebo treatment.[66,67] Autologous materials, to date, are neither produced in regulated doses nor FDA controlled. While a benefit may exist to the use of autologous growth factors, the cost and questionable evidence of efficacy does not warrant their use as a primary choice when considering appropriate and advanced therapy. The use of autologous materials stimulated significant interest and studies on the use of recombinant materials.[68–71] Becaplermin is a recombinant human platelet-derived growth factors and is the only currently approved growth factor indicated for the use of diabetic neuropathic plantar foot ulcers. Becaplermin is a recombinant, dosed, and regulated product.[72] This product has been shown through randomized, controlled, double-blinded multisite trials to be both effective and safe when used as directed. Study results indicated a statistically significant difference between uses of the treatment drug versus control therapy.[73–76] While currently indicated and FDA approved for use on diabetic ulcers, becaplermin’s mechanism of action is not specific to diabetic wounds. Becaplermin may be prescribed by the healthcare provider for any ulcer where it is believed the product may be of benefit to the patient in the treatment of his or her wound, including pressure, venous, and other chronic ulcers, and where there is no contraindication to product use. Other bioengineered products may be of similar benefit when used on wounds other than those indicated in the product recommendations. Current publications also indicate a statistically significant difference favoring becaplermin in the treatment of pressure ulcers.[77] Patients with diabetic ulcers are at high risk of developing complications, which may lead to amputation. A physician may argue that it was not possible to prevent an amputation although the community standard of care was applied. The patient or the legal advisor may reasonably argue that while standard of care is the care given by the majority of clinicians in the community, the amputation might have been avoided if appropriate or advanced care had been administered. Any reasonable therapy that expedites closure of the wound and decreases risk of morbidity and mortality associated with diabetic and other ulcers needs to be considered as a primary line of therapy and included in the care of the diabetic foot ulcer. Healthcare providers may be hesitant to deviate from their medical training or from community norms. New treatment modalities are neglected when the clinician has become comfortable with past treatment regiments. Clinicians need to be encouraged to carefully read literature associated with new products and, when supported by well-designed clinical trials and scientific literature, apply the modalities as a means to expedite wound closure. Product cost, ability to significantly reduce the time to closure, advantages over other treatment modalities, and patient compliance are all considerations for the final treatment selection. Summary Cost containment, managed healthcare, and capitated systems often consider unit cost of treatments while neglecting the overall cost associated with long-term treatments resulting from complications arising from inappropriate care of an ulcer, particularly in the diabetic population. Standard care may be the accepted care in the medical community, but it may not be appropriate care. Advanced treatment modalities are appropriate and need to become part of standard care in the high-risk population with chronic ulcers. Standard care guidelines may no longer be considered the sole determinant of what may be appropriate for all ulcers, particularly diabetic ulcers, treated by the healthcare provider in the community. The treatment ultimately selected for each patient may have a significant impact on results. Considering each patient’s individual living environment, compliance, ability to self administer care, socioeconomic status and ability to purchase or obtain prescribed products, ambulatory status, wound status, and overall medical history will assist with selection of the most appropriate treatment modality and continuum of care. The healthcare provider has a duty to provide appropriate medical care whenever possible. This manuscript has provided a general overview of factors to consider when caring for the diabetic foot ulcer.