A Prospective, Randomized, Multi-Center Comparative Study of Amniotic Membrane Wound Graft Application versus Tissue Engineered Skin Substitute in the Management of Non Healing Diabetic Foot Ulcers

Background: Allogeneic grafts derived from amnion/chorion are known to be efficacious in healing chronic diabetic foot ulcerations (DFUs).  Aseptically processed grafts may have a benefit over those that are terminally sterilized.

Purpose: The goal of this study was to compare aseptically processed dehydrated human amnion and chorion allograft (dHACA) versus a tissue engineered skin substitute (TESS) in facilitating wound closure in nonhealing DFUs.

Methods: The research was reviewed and approved by the Western Institutional Review Board and registered on https://clinicaltrials.gov/. Patients with non healing DFUs treated with SOC (off-loading, appropriate debridement, and moist wound care) after a 2-week screening period were randomized to either SOC with TESS or wound-size-specific dHACA  plus SOC applied weekly for up to 12 weeks. Endpoints for this 12 week clinical trial included percent of patient's healed, time to healing, number of graft used and graft wastage.  

Results: At study conclusion of 12 weeks  27/30(90%) of the dHACA-treated DFUs plus SOC healed compared with 12/30(40%) treated with TESS combined with SOC (p=4.9 x 10-5).  A corresponding mean time to healing of 32 days(95%CI: 22.3-41.0) for dHACA treated wounds versus 63 days(95%CI: 54.1-72.6) for the TESS treated wounds was appreciated (p=3.2 x 10-5).  At 12 weeks, the mean number of grafts used per healed wound for the dHACA group was 4.4 (SD=3.71); median: 2.5 and for the TESS was 7.5 (SD=3.52); median: 6.  The mean graft wastage for the dHACA treated wounds was 36.3% (SD: 15.03; median: 38.2) and was 94.6% for the TESS treated wound (SD: 6.26; median: 97.6), (p=1 x10-250).

Conclusion: n conclusion, aseptically processed dHACA heals diabetic foot wounds significantly faster than TESS at 12 weeks with a significantly less graft usage and wastage.