A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC

This study examines a patient population with a diabetic foot ulcer (DFU) having adequate perfusion without clinical signs and symptoms of infection. Historical data has demonstrated that around 30% of DFUs heal within 12 weeks using standard care alone. However, roughly half of patients suffering from DFUs require additional measures, including advanced therapy. It is hypothesized that weekly applications of the human placental allograft BR-AC applied to a nonhealing DFU will result in a higher rate of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone. This study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing. A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow up period will consist of a four-week follow up with two visits at each two-week interval.