A Retrospective Crossover Study of the Use of Aseptically Processed Placental Membrane in the Treatment of Chronic Diabetic Foot Ulcers

Background. In a recently published, prospective randomized controlled trial (RCT) comparing aseptically processed dehydrated human amnion/chorion allograft (dHACA) to standard of care (SOC), 85% wound closure rates were reported in the dHACA arm while only 25% of patients in the SOC arm healed. Objective. The purpose of this retrospective crossover study is to evaluate the effectiveness of dHACA in those patients that failed to respond to the SOC treatments and who exited the original study after failing up to 12 weeks of SOC treatment. Materials and Methods. Patients with nonhealing wounds from the SOC arm after exit from the original study were offered weekly adjunctive applications of dHACA (AmnioBand; Musculoskeletal Transplant Foundation, Edison, NJ) for up to 12 weeks. The primary endpoint was the proportion of wounds completely healed at 12 weeks. Secondary endpoints included the difference in wound area from baseline to the end of study and the percentage area reduction (PAR). Results. Eleven patients were eligible to participate; wounds for 9 of the 11 patients healed (82%). The mean wound area decreased from 1.7 cm2 to 0.2 cm2 (P = .0005), with a corresponding mean PAR of 92%. Of the 2 wounds that failed to heal, 1 diabetic foot ulcer (DFU) decreased in area by 91% and the other by 26%. Conclusions. The results of this crossover study support the conclusions of the original RCT, which determined that aseptically processed dHACA is an effective means to treat recalcitrant DFUs. Further studies, including comparative clinical trials, may offer additional information on this unique aseptically processed graft in the healing of indolent wounds.