A Confirmatory Study on the Efficacy of dHACM Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study of 100 Patients from 14 Wound Clinics

Background: A randomized, controlled multi-center clinical trial was conducted at 14 wound care centers in the United States to confirm the efficacy of dehydrated human amnion/chorion membrane* (dHACM) allograft for the treatment of chronic lower extremity ulcers in persons with diabetes.

Methods: Patients with a lower extremity ulcer of at least 4 weeks duration were entered into a 2 week study run-in phase and treated with alginate wound dressings and appropriate offloading. Those with less than 25% wound closure at run-in completion were randomly assigned to either receive weekly dHACM application in addition to offloading, or to continue the run-in standard of care with alginate wound dressings that excluded dHACM. Patients were followed in the treatment phase weekly for 12 weeks, with final follow-up at week 16. One-hundred patients completed the study, with 48 in the dHACM group and 52 in the no-dHACM group.

Results: Primary study outcome was percent of study ulcers completely healed during the treatment period. Weekly dHACM application was significantly associated with complete wound healing compared with not receiving dHACM (77% vs 42% healed at 12 weeks, p=0.0005). A Kaplan-Meier analysis was performed to compare the time-to-healing performance with/without dHACM, showing a significantly improved time-to-healing with use of allograft, Log-Rank p<0.0001). Adjusting for co-variates associated with healing, Cox regression analysis showed subjects treated with dHACM were more than three times as likely to heal completely within 12 weeks than those not receiving dHACM (Hazard Ratio: 3.40, 95% confidence interval 1.98-5.84, p<0.0001), and inadequate debridement was associated with a 63% less likelihood of healing (Hazard Ratio: 0.37, 95% confidence interval 0.16-0.82, p=0.014). At 16 week follow-up, 92% of dHACM and 86% of no-dHACM healed ulcers remained closed.

Conclusion: The results of this multi-center study confirm that dHACM is an efficacious treatment for lower extremity ulcers in a heterogeneous patient population.