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

Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this s...

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Bibliographic Details
Published in:International wound journal 2018-12, Vol.15 (6), p.950-957
Main Authors: DiDomenico, Lawrence A, Orgill, Dennis P, Galiano, Robert D, Serena, Thomas E, Carter, Marissa J, Kaufman, Jarrod P, Young, Nathan J, Jacobs, Allen M, Zelen, Charles M
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Amnion - transplantation
amnion/chorion graft
Chorion - transplantation
complete wound healing
Diabetic Foot - surgery
diabetic foot ulcer
Female
Humans
Male
Middle Aged
Original
Prospective Studies
randomised controlled trial
Standard of Care
time to heal
Transplantation, Homologous - methods
Treatment Outcome
Wound Healing - physiology
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Summary:Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this study was to report on the full trial results of 80 patients where dHACA was compared with standard of care (SOC) in achieving wound closure in non‐healing DFUs. After a 2‐week screening period, during which patients with DFUs were unsuccessfully treated with SOC, patients were randomised to either SOC alone or SOC with dHACA applied weekly for up to 12 weeks. At 12 weeks, 85% (34/40) of the dHACA‐treated DFUs healed, compared with 33% (13/40) treated with SOC alone. Mean time to heal within 12 weeks was significantly faster for the dHACA‐ treated group compared with SOC, 37 days vs 67 days in the SOC group (P = .000006). Mean number of grafts used per healed wound during the same time period was 4.0, and mean cost of the tissue to heal a DFU was $1771. The authors concluded that aseptically processed dHACA heals DFUs significantly faster than SOC at 12 weeks.
ISSN:1742-4801
1742-481X
DOI:10.1111/iwj.12954