DiDomenico LA, Orgill DP, Galiano RD, Serena TE, Carter MJ, Kaufman JP, Young NJ, Zelen CM, et al.
Plastic and reconstructive surgery. Global open. Date of publication 2016 Oct 12;volume 4(10):e1095.
1. Plast Reconstr Surg Glob Open. 2016 Oct 12;4(10):e1095. eCollection 2016 Oct.
Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot
Ulcerations: Prospective, Randomized Clinical Trial.
DiDomenico LA(1), Orgill DP(1), Galiano RD(1), Serena TE(1), Carter MJ(1),
Kaufman JP(1), Young NJ(1), Zelen CM(1).
Author information:
(1)Lower Extremity Institute for Research and Therapy, Youngstown, Ohio;
Department of Plastic Surgery, Brigham and Women's Hospital, Boston, Mass.;
Division of Plastic Surgery, Feinberg School of Medicine, Northwestern
University, Chicago, Ill.; Serena Group, Cambridge, Mass.; Strategic Solutions,
Inc., Cody, Wyo.; General Surgery, Premier Surgical, Brick, N.J.; †Martinsville
Research Institute, Martinsville, Va.; and ‡Professional Education and Research
Institute, Roanoke, Va.
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.
DOI: 10.1097/GOX.0000000000001095
PMCID: PMC5096542
PMID: 27826487
