A Prospective Multi-center Study of a Weekly Application Regimen of Viable Human Amnion Membrane Allograft in the Management of Non-healing Diabetic Foot Ulcers

Introduction: Non-healing diabetic foot ulcers (DFUs) frequently represent a significant clinical challenge. Cryopreserved viable human amnion membrane (vHAMA) has shown great promise in the treatment of recalcitrant DFUs as a supplement to standard of care. Adding these 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.

Purpose: The purpose of this prospective study was to report the efficacy and safety of this novel graft in treating non-healing diabetic foot ulcers.

Research: The research was reviewed and approved by the Western Institutional Review Board. Twenty patients with non-healing DFUs treated with SOC (off-loading, appropriate debridement, and moist wound care) after a two-week screening period were enrolled and received weekly application of vHAMA for up to 12 weeks. Primary endpoint of this clinical trial was percent of patients healed and completely epithialized at 12 weeks.

Conclusion: At study conclusion, 85% of the patient receiving weekly application of vHAMA healed. In conclusion, aseptically processed vHAMA should be considered as a viable option for the refractory diabetic foot wound.