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

Gerit Mulder, DPM, MS, David Armstrong, DPM, Susie Seaman, MSN, NP, CETN

Disclosures

Wounds. 2003;15(4) 

In This Article

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.[58,59,60,61]

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.[62,63,64]

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.[68,69,70,71]

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.[73,74,75,76]

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.

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