Armstrong DG, Galiano RD, Orgill DP, Glat PM, Carter MJ, Di Domenico LA, Reyzelman AM, Zelen CM, et al.
International wound journal. Date of publication 2022 May 1;volume 19(4):932-944.
1. Int Wound J. 2022 May;19(4):932-944. doi: 10.1111/iwj.13759. Epub 2022 Jan 26.
Multi-centre prospective randomised controlled clinical trial to evaluate a
bioactive split thickness skin allograft vs standard of care in the treatment of
diabetic foot ulcers.
Armstrong DG(1), Galiano RD(2), Orgill DP(3), Glat PM(4), Carter MJ(5), Di
Domenico LA(6), Reyzelman AM(7), Zelen CM(3).
Author information:
(1)Department of Surgery, Keck School of Medicine, University of Southern
California, Los Angeles, California, USA.
(2)Division of Plastic Surgery, Feinberg School of Medicine, Northwestern
University, Chicago, Illinois, USA.
(3)Professional Education and Research Institute, Roanoke, Virginia, USA.
(4)Department of Surgery, Drexel University School of Medicine, Philadelphia,
Pennsylvania, USA.
(5)Strategic Solutions, Inc, Bozeman, Montana, USA.
(6)Lower Extremity Institute for Research and Therapy, Youngstown, Ohio, USA.
(7)Center for Clinical Research, San Francisco, California, USA.
Erratum in
Int Wound J. 2022 Aug;19(5):1276.
Diabetic foot ulcers (DFUs) pose a significant risk for infection and limb loss.
Advanced wound therapies including human skin allografts have shown promise in
resolving these challenging wounds. The primary objective of this randomised,
prospective study was to compare the response of 100 subjects with non-healing
DFUs of which 50 were treated with a cryopreserved bioactive split thickness
skin allograft (BSA) (TheraSkin; Misonix,Inc., Farmingdale, NY) compared with 50
subjects treated with standard of care (SOC, collagen alginate dressing) at
12 weeks. Both groups received standardised care that included glucose
monitoring, weekly debridement's as appropriate, and an offloading device. The
primary endpoint was proportion of full-thickness wounds healed at 12 weeks,
with secondary endpoints including differences in percent area reduction (PAR)
at 12 weeks, changes in Semmes-Weinstein monofilament score, VAS pain, and
w-QoL. The result illustrated in the intent-to-treat analysis at 12 weeks showed
that 76% (38/50) of the BSA-treated DFUs healed compared with 36% (18/50)
treated with SOC alone (adjusted P = .00056). Mean PAR at 12 weeks was 77.8% in
the BSA group compared with 49.6% in the SOC group (adjusted P = .0019). In
conclusion, adding BSA to SOC appeared to significantly improve wound healing
with a lower incidence of adverse events related to treatment compared with SOC
alone.
© 2022 The Authors. International Wound Journal published by
Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.13759
PMCID: PMC9013597
PMID: 35080127 [Indexed for MEDLINE]
Conflict of interest statement: This study was funded through a research grant
from Misonix, Inc provided to the Professional Education and Research Institute
(PERI), which Charles M. Zelen, DPM is medical director. David G. Armstrong,
DPM, MD, PhD received research funds from PERI to serve as Co‐Principal
Investigator/Study Chair for this trial and to design and administrate the
trial, review study photos, and also assist with the writing and review of the
manuscript. Robert D. Galiano, MD received research funds from PERI to serve as
Co‐Principal Investigator/Study Chair for this trial and to design and
administrate the trial, review study photos and also assist with the writing and
review of the manuscript. Dennis P. Orgill, MD, PhD received research funds to
serve as a validating/adjudicating plastic surgeon to review study photos and
assist with the writing and review of the manuscript. Paul M. Glat, MD received
research funds to serve as a validating/adjudicating plastic surgeon to review
study photos and assist with the writing and review of the manuscript. Marissa
J. Carter, PhD received research funds to provide the statistical analysis plan,
and provide the statistical analysis for this trial and assist with writing of
the result section of the manuscript. Lawrence A. Didomenico, DPM is the medical
director of LEIRT and his company received research funds to serve as a site
investigator for this trial and to assist with the writing and review of the
manuscript. Alexander M. Reyzelman, DPM received research funds and served a
site investigator for this trial and assisted with the writing and review of the
manuscript. Charles M. Zelen, DPM is the medical director and president of the
PERI and his company received research funds to administrate the clinical trial
and write the paper for publication. There is no other conflict of interests
with any of the authors in relationship to this study, or with regard to
Misonix, Inc. IRB conflict of interest statements are on file with PERI.
