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


CONCLUSIONS
Aseptically processed dHACA heals diabetic foot wounds significantly faster than SOC at 6 and 12 weeks with minimal graft wastage.
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.
Lawrence A
LA
DiDomenico
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.
Dennis P
DP
Orgill
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.
Robert D
RD
Galiano
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.
Thomas E
TE
Serena
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.
Marissa J
MJ
Carter
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.
Jarrod P
JP
Kaufman
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.
Nathan J
NJ
Young
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.
Charles M
CM
Zelen