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

Lawrence A DiDomenico, Dennis P Orgill, Robert D Galiano, Thomas E Serena, Marissa J Carter, Jarrod P Kaufman, Nathan J Young, Charles M Zelen, Lawrence A DiDomenico, Dennis P Orgill, Robert D Galiano, Thomas E Serena, Marissa J Carter, Jarrod P Kaufman, Nathan J Young, Charles M Zelen

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.

Figures

Fig. 1.
Fig. 1.
Diagram of the aseptic processing of human amniotic membranes from placental tissue to produce a structural graft of dHACA for wound placement.
Fig. 2.
Fig. 2.
Flowchart of trial participants.
Fig. 3.
Fig. 3.
Bar graph showing complete wound healing at 6 weeks for the dHACA and SOC groups, tested by chi square (P = 0.001).
Fig. 4.
Fig. 4.
Percentage of wounds healed weekly up to 12 weeks by treatment group (not statistically tested at 12 wk).
Fig. 5.
Fig. 5.
Kaplan–Meier plot of time to heal within 12 weeks by treatment group, tested by the log rank test (P = 0.00073).
Fig. 6.
Fig. 6.
Weekly percentage wound area reduction up to week 12 (ITT basis) by treatment group (not statistically tested at 12 wk).

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