Armstrong DG, Orgill DP, Galiano RD, Glat PM, DiDomenico LA, Carter MJ, Zelen CM, et al.
International wound journal. Date of publication 2022 May 1;volume 19(4):791-801.
1. Int Wound J. 2022 May;19(4):791-801. doi: 10.1111/iwj.13675. Epub 2021 Aug 21.
A multi-centre, single-blinded randomised controlled clinical trial evaluating
the effect of resorbable glass fibre matrix in the treatment of diabetic foot
ulcers.
Armstrong DG(1), Orgill DP(2), Galiano RD(3), Glat PM(4), DiDomenico LA(5),
Carter MJ(6), Zelen CM(2).
Author information:
(1)Department of Surgery Keck School of Medicine, University of Southern
California, Los Angeles, California, USA.
(2)Professional Education and Research Institute, Roanoke, Virginia, USA.
(3)Division of Plastic Surgery, Feinberg School of Medicine, Northwestern
University, Chicago, Illinois, USA.
(4)Department of Surgery, Drexel University School of Medicine, Philadelphia,
Pennsylvania, USA.
(5)Lower Extremity Institute for Research and Therapy, Youngstown, Ohio, USA.
(6)Strategic Solutions, Inc., Bozeman, Montana, USA.
Diabetic foot ulcers (DFUs) are at risk for detrimental complications even with
current, standard of care (SOC) treatments. The primary objective of this
randomised controlled trial was to compare a unique resorbable glass microfiber
matrix (Mirragen; Advanced Wound Matrix [BBGFM]; ETS Wound Care, Rolla,
Missouri) compared with a standard of care group (SOC, collagen alginate
dressing) at 12 weeks. Both groups received standard diabetic foot care
including glucose monitoring, weekly debridements when needed and an offloading
device. The primary endpoint was proportion of full-thickness, non-infected,
non-ischaemic wounds healed at 12 weeks, with secondary endpoints including
percent area reduction (PAR) and changes in Semmes-Weinstein monofilament
testing. The result illustrated in the intent-to-treat analysis at 12 weeks
showed that 70% (14/20) of the BBGFM-treated DFUs healed compared with 25%
(5/20) treated with SOC alone (adjusted P = .006). Mean PAR at 12 weeks was 79%
in the BBGFM group compared with 37% in the SOC group (adjusted P = .027). Mean
change in neuropathic score between baseline and up to 12 weeks of treatment was
2.0 in the BBGFM group compared with -0.6 in the SOC group where positive
improvement in scores are better (adjusted P = .008). The mean number of BBGFM
applications was 6.0. In conclusion, adding BBGFM to SOC significantly improved
wound healing with no adverse events related to treatment compared with SOC
alone.
© 2021 The Authors. International Wound Journal published by
Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.13675
PMCID: PMC9013587
PMID: 34418302 [Indexed for MEDLINE]
Conflict of interest statement: This study was funded through a research grant
from ETS WoundCare provided to the Professional Education and Research Institute
(PERI), for which Charles M Zelen, DPM is medical director. David Armstrong,
DPM, MD, PhD received research funds from PERI to serve as Principal
Investigator for this trial and to design and administrate the trial and also
assist with the writing and review of the manuscript. Dennis 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.
Robert Galiano, 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. Paul 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. Lawrence Didomenico, DPM received
research funds and served as a site investigator for this trial and assisted
with the writing and review of the manuscript. Marissa Carter, PhD received
research funds to provide the statistical analysis plan, and provide the
statistical analysis for this trial and assist with the writing of the result
section of the manuscript. Charles M Zelen, DPM is the medical director of the
PERI and his company received research funds to administrate the clinical trial
and write the paper for publication. There are no other conflict of interests
with any of the authors in relationship to this study, or with regard to ETS
WoundCare. IRB conflict of interest statements are on file with PERI.
