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

摘要

Category:DiabetesIntroduction/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...