Prospective, Randomized, Controlled, Comparative Effectiveness Trial Examining Healing, of Acellular-Reticular Human-Dermis Versus Standard Care in Treatment of Diabetic Foot Ulcers

Abstract

Category: Diabetes Introduction/Purpose: One sequitur of prolonged diabetes is the development of diabetic foot ulcers (DFUs), which are often complicated by lower extremity amputation (LEA). The annual incidence of DFUs and LEAs calculated from the Medicare population is approximately 6% and 0.4% respectively. Many acellular dermal matrices have been shown to successfully heal these wounds. In this study, we examined a novel, human, acellular reticular dermis with an open, porous, uniform framework aseptically processed to retain endogenous matrix protein versus standard of care in non healing diabetic foot wounds. Methods: This study was a multicenter, randomized controlled trial in which diabetic patients having at least one non-healing neuropathic foot ulcer that failed at least 4 weeks of documented conservative care with adequate blood flow and a lack of renal failure were screened for a 2-week period. Those meeting inclusion and exclusion criteria, after 2-weeks of offloading and moist wound care if the diabetic foot ulcer (DFU) failed to reduce in area by 20% were randomized 1:1 to standard of care (SOC) or human acellular dermal tissue (HADT) applied weekly plus SOC for up to 12 weeks Results: At 6 weeks, 65% of the HADT–treated wounds had healed (13/20) compared to 5% (1/20) of the wounds that received SOC alone (adjusted p=.00028). At 12 weeks, 80% of the HADT–treated wounds (16/20) had healed compared to 20% (4/20) of the DFUs in the SOC group (adjusted p=.00036). Mean time to heal within 12 weeks was 39.6 days for the HADT group compared to 77.0 days for the SOC group (adjusted p=.00014). There was no incidence of increased adverse or serious adverse events between groups, nor adverse events related to the graft. The mean and median costs to closure in the HADT group were $1475.00 and $963.00, respectively, per healed wound Conclusion: These findings demonstrate that weekly application of acellular human reticular dermis is an effective treatment for non-healing diabetic foot wounds. Wound-size-specific pieces may allow for decreased cost to closure and wastage.