Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial

Abstract

Background:Allogeneic grafts derived from amnion/chorion are known to be efficacious in healing chronic diabetic foot ulcerations (DFUs). The goal of this study was to compare aseptically processed dehydrated human amnion and chorion allograft (dHACA) versus standard of care (SOC) in facilitating wound closure in nonhealing DFUs.Methods:Patients with DFUs treated with SOC (off-loading, appropriate debridement, and moist wound care) after a 2-week screening period were randomized to either SOC or wound-size-specific dHACA (AmnioBand, Musculoskeletal Transplant Foundation, Edison, N.J.) applied weekly for up to 12 weeks plus SOC. Primary endpoint was the percentage of wounds healed at 6 weeks between groups.Results:At 6 weeks, 70% (14/20) of the dHACA-treated DFUs healed compared with 15% (3/20) treated with SOC alone. Furthermore, at 12 weeks, 85% (17/20) of the DFUs in the dHACA group healed compared with 25% (5/20) in the SOC group, with a corresponding mean time to heal of 36 and 70 days, respectively. At 12 weeks, the mean number of grafts used per healed wound for the dHACA group was 3.8 (median 3.0), and mean cost of the tissue to heal a DFU was $1400. The mean wastage at 12 weeks was 40%. One adverse event and 1 serious adverse event occurred in the dHACA group; neither was graft related. Three adverse events and 1 serious adverse event occurred in the SOC group.Conclusion:Aseptically processed dHACA heals diabetic foot wounds significantly faster than SOC at 6 and 12 weeks with minimal graft wastage.

Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi‐centre clinical trial in 80 patients

“…By 12 weeks, the mean number of dHACA applications in the full trial (4.0) was almost identical compared with our interim results (3.8), with similar mean percentage wastage figures (35.3 vs 40.0). Our costs for healed dHACA‐treated wounds over 12 weeks were slightly higher in the full trial ($1771) compared with the interim results ($1400); however, the mean starting wound size was also slightly higher in the full cohort.…”

“…The results of the full clinical trial in which 80 patients were enrolled mirrored the interim results . Clinical outcomes in terms of proportion of wounds healed, time to heal, and PAR at both 6 and 12 weeks were all statistically superior for the dHACA plus SOC group compared with the SOC group.…”

Characterisation of dehydrated amnion chorion membranes and evaluation of fibroblast and keratinocyte responses in vitro

“…Placental membranes have a long documented history as being used to treat both chronic and acute wounds . Clinical studies of placental membranes have demonstrated improved outcomes in a variety of wound types, including: acute wounds, DFUs, and venous leg ulcers . Placental tissues are processed in various ways, including: cryopreservation, hypothermic storage, and dehydration .…”

Update on management of diabetic foot ulcers

“…There have been several recent studies comparing dHACMs to standard of care that have found improved rates of wound healing and wound closure. 78,79 Studies comparing dHACMs to bioengineered skin substitutes have had various outcomes. 80,81 Another area of interest is the use of cryopreserved umbilical cord as adjunctive therapy.…”