A Prospective, Randomized, Controlled, Multi-center Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft Application versus Standard of Care in the Management of Non Healing Venous Leg Ulcers

Abstract Body: Venous leg ulcerations (VLUs) frequently represent a significant clinical challenge. Dehydrated human amnion and chorion allografts have shown great promise in the treatment of recalcitrant VLUs when compared to standard wound care (SOC) alone which includes debridement followed by multilayer compression therapy with a primary absorptive dressing. Adding placental grafts into the treatment regimen is often successful as they are rich in extracellular matrix proteins, growth factors, and cytokines, and as such can induce angiogenesis and dermal fibroblast proliferation which can lead to accelerated healing. Aseptically processed grafts may have a benefit over those that are terminally sterilized. The goal of this study was to compare aseptically processed dehydrated human amnion and chorion allograft (dHACA) applied weekly or biweekly combined with standard wound care versus standard of care alone in facilitating wound closure in non-healing VLUs. The research was reviewed and approved by the Western Institutional Review Board and registered on Clinical Trials.gov. Patients with non healing VLUs treated with SOC (appropriate debridement, primary absorptive dressing and multilayer compression) after a 2-week screening period were randomized to either receive SOC (20 patients) or wound-size-specific dHACA plus SOC applied weekly (20 patients) or wound-size-specific dHACA plus SOC applied bi-weekly (20 patients) for up to 12 weeks. Primary endpoint of this clinical trial was percent of patients healed and completely epithialized at 12 weeks. At study conclusion, weekly and biweekly application of dHACA with SOC  healed 75% of the wounds versus 30% receiving only SOC (p=0.001); The mean percent area reduction (PAR) was 80.7 (SD: 46.93) for the two groups receiving dHACA and  57.8 (SD: 49.48)  for  those receiving only SOC (p= 0.012)    In conclusion, aseptically processed dHACA should be considered as a viable option for the refractory venous leg wounds.