Zelen CM, Orgill DP, Serena TE, Galiano RE, Carter MJ, DiDomenico LA, Keller J, Kaufman JP, Li WW, et al.
International wound journal. Date of publication 2018 Oct 1;volume 15(5):731-739.
1. Int Wound J. 2018 Oct;15(5):731-739. doi: 10.1111/iwj.12920. Epub 2018 Apr 22.
An aseptically processed, acellular, reticular, allogenic human dermis improves
healing in diabetic foot ulcers: A prospective, randomised, controlled,
multicentre follow-up trial.
Zelen CM(1), Orgill DP(2), Serena TE(3), Galiano RE(4), Carter MJ(5), DiDomenico
LA(6), Keller J(7), Kaufman JP(8), Li WW(9).
Author information:
(1)Professional Education and Research Institute, Roanoke, Virginia.
(2)Division of Plastic Surgery, Brigham and Women's Hospital, Boston,
Massachusetts.
(3)Serena Group, Cambridge, Massachusetts.
(4)Division of Plastic Surgery; Feinberg School of Medicine, Northwestern
University, Chicago, Illinois.
(5)Strategic Solutions, Inc., Cody, Wyoming.
(6)Lower Extremity Institute for Research and Therapy, Youngstown, Ohio.
(7)Shenandoah Lower Extremity Research, Troutville, Virginia.
(8)General Surgery, Premier Surgical, Brick, New Jersey.
(9)The Angiogenesis Foundation, Cambridge, Massachusetts.
Aseptically processed human reticular acellular dermal matrix (HR-ADM) has been
previously shown to improve wound closure in 40 diabetic patients with
non-healing foot ulcers. The study was extended to 40 additional patients (80 in
total) to validate and extend the original findings. The entire cohort of 80
patients underwent appropriate offloading and standard of care (SOC) during a
2-week screening period and, after meeting eligibility criteria, were randomised
to receive weekly applications of HR-ADM plus SOC or SOC alone for up to 12
weeks. The primary outcome was the proportion of wounds closed at 6 weeks.
Sixty-eight percent (27/40) in the HR-ADM group were completely healed at 6 weeks
compared with 15% (6/40) in the SOC group. The proportions of wounds healed at 12
weeks were 80% (34/40) and 30% (12/40), respectively. The mean time to heal
within 12 weeks was 38 days for the HR-ADM group and 72 days for the SOC group.
There was no incidence of increased adverse or serious adverse events between
groups or any graft-related adverse events. The mean and median HR-ADM product
costs at 12 weeks were $1200 and $680, respectively. HR-ADM is clinically
superior to SOC, is cost effective relative to other comparable treatment
modalities, and is an efficacious treatment for chronic non-healing diabetic foot
ulcers.
© 2018 The Authors. International Wound Journal published by Medicalhelplines.com
Inc and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.12920
PMID: 29682897 [Indexed for MEDLINE]
