Ulceration occurs in 4%–10% of people with diabetes in the United States and leads to amputation in approximately 30% of patients with diabetes who are 40 years and older.¹ Each foot ulcer is associated with direct costs that can frequently exceed $45,000.² The American Diabetes Association estimates that more than one-half of all amputations can be prevented with proper patient therapy. Diabetic neuropathy leads to functional impairment of microcirculation and can result in foot tissue hypoxia and reduced healing capacity, even in the presence of adequate blood flow. The standard treatment recommended by the American College of Foot and Ankle Surgeons consists of extensive debridement of necrotic tissue, treatment of infection, non-weightbearing or offloading techniques that decrease the pressure applied on the affected extremity, and arterial revascularization, if indicated.³ Topical treatments for diabetic foot ulcers include enzymatic debridement, total contact casting, hyperbaric oxygen, antibiotics, growth factors, and dressings that maintain a moist wound environment while also protecting granulating tissue from mechanical injury. Recently, several tissue/cell-based (human skin equivalents) wound dressings have been developed and are undergoing clinical evaluation as well.

The present study compared OASIS^® Wound Matrix [ECM] (Healthpoint, Fort Worth, Tex), which is an acellular, bioactive, collagen-based wound dressing made from porcine intestinal submucosa to Dermagraft^® [LSE] (Advanced BioHealing, La Jolla, Calif), a living skin equivalent consisting of human fibroblast cells derived from newborn foreskin tissue that have been seeded onto a bioabsorbable polyglactin mesh scaffold.

In a randomized, non-blinded study, the two materials were used for treating full-thickness diabetic ulcers as an adjunct to standard therapy that consisted of wound debridement and use of saline moistened gauze dressings. The focus of the study was to compare patient outcomes following diabetic ulcer treatment with these two materials. The relative rate of wound closure when an acellular collagen-based matrix was compared to a living cellular product became a point of particular interest in the course of this study. The living cellular product (LSE) was essentially devoid of collagen, but contained living cells. The authors hypothesized that there would be no difference in the rate of wound closure or in the percentage of wounds that achieved closure when comparing treatment with an acellular collagen-based matrix versus a living cellular material.

Materials and Methods

This study involved 4 study sites (Weil Foot and Ankle Institute, Des Plaines, Ill; Coastal Podiatry, Inc., Virginia Beach, Va; Ocean County Foot and Ankle Surgical Associates, Toms River, NJ; The Foot and Ankle Institute of South Florida, South Miami, Fla) in which patients were randomized to treatment with either an acellular, porcine-derived, bioactive, collagen matrix material ([ECM], OASIS), or a living skin equivalent ([LSE], Dermagraft) consisting of human fibroblast cells derived from newborn foreskin tissue that have been seeded onto a bioabsorbable polyglactin mesh scaffold.