Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers

An estimated 29.1 million people currently suffer from diabetes.1 The most common complication among diabetic patients is neuropathy, a condition involving poor sensation in the extremities.2 Around 8% of newly diagnosed diabetic patients and more than 50% of patients with chronic diabetes will develop neuropathy,3 which is a contributory cause of diabetic foot ulcers (DFUs). It is estimated that the lifetime risk for developing a foot ulcer among the diabetic population is 25%.4 DFUs can severely impact patients’ quality of life and health. Patients with DFUs report significantly worse quality of life, including significantly lower levels of physical functioning, social functioning, physical role, and health experience than patients without DFUs.5 These difficult-to-treat ulcers can also lead to serious complications such as amputation or death, with the 5-year mortality rate of patients with DFUs at 40%.6 In addition to affecting the quality of life and health of patients, DFUs are expensive to treat. The cost of treating a single diabetic patient with a DFU in the United States averaged $31,419 over 1 year, more than twice the expense of a diabetic patient without a DFU.7 The current standard conventional care for DFUs includes debridement, off-loading of the wound, proper dressing of the wound, and infection control, if necessary.8 Standard care has a wide range of 12- and 16-week healing rates, with rates reported in the literature between 21.3% and 46.2%.9-12 An alternative treatment of DFUs is a human acellular dermal matrix (ADM), which can provide a scaffold for tissue growth. There are few large-scale studies evaluating ADM use in DFUs, but 12-week healing rates are reported as high as 69.6%.11,13 A particular ADM, DermACELL and referred to hereafter as D-ADM, has shown success in early case series,14,15 which prompted this larger trial. D-ADM is prepared using a unique decellularization process,16 resulting in a material with thorough DNA removal, retention of biomechanical strength, and provided fully hydrated at room temperature. The product is also terminally sterilized to a sterility assurance level of 1 × 10−6, consistent with medical device regulations, although classified as a human tissue.16 The purpose of this study was to compare the healing rate and other healing metrics of D-ADM with conventional care and an active comparator, Graftjacket (hereafter referred to as GJ-ADM).