Armstrong DG, Orgill DP, Galiano RD, Glat PM, Kaufman JP, Carter MJ, DiDomenico LA, Zelen CM, et al.
International wound journal. Date of publication 2022 Aug 1;volume 19(5):1197-1209.
1. Int Wound J. 2022 Aug;19(5):1197-1209. doi: 10.1111/iwj.13715. Epub 2022 Jan
9.
Use of a purified reconstituted bilayer matrix in the management of chronic
diabetic foot ulcers improves patient outcomes vs standard of care: Results of a
prospective randomised controlled multi-centre clinical trial.
Armstrong DG(1), Orgill DP(2), Galiano RD(3), Glat PM(4), Kaufman JP(5), Carter
MJ(6), DiDomenico LA(7), Zelen CM(2).
Author information:
(1)Division 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)Surgery and Pediatrics, Drexel University College of Medicine, St.
Christopher's Hospital for Children, Philadelphia, Pennsylvania, USA.
(5)Department of Surgery, Temple University School of Medicine and McGowan
Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh,
Pennsylvania, USA.
(6)Strategic Solutions, Inc., Bozeman, Montana, USA.
(7)Lower Extremity Institute for Research and Therapy, Youngstown, Ohio, USA.
Diabetic foot infections continue to be a major challenge for health care
delivery systems. Following encouraging results from a pilot study using a novel
purified reconstituted bilayer matrix (PRBM) to treat chronic diabetic foot
ulcers (DFUs), we designed a prospective, multi-centre randomised trial
comparing outcomes of PRBM at 12 weeks compared with a standard of care (SOC)
using a collagen alginate dressing. The primary endpoint was percentage of
wounds closed after 12 weeks. Secondary outcomes included assessments of
complications, healing time, quality of life, and cost to closure. Forty
patients were included in an intent-to-treat (ITT) and per-protocol (PP)
analysis, with 39 completing the study protocol (n = 19 PRBM, n = 20 SOC).
Wounds treated with PRBM were significantly more likely to close than wounds
treated with SOC (ITT: 85% vs 30%, P = .0004, PP: 94% vs 30% P = .00008), healed
significantly faster (mean 37 days vs 67 days for SOC, P = .002), and achieved a
mean wound area reduction within 12 weeks of 96% vs 8.9% for SOC. No adverse
events (AEs) directly related to PRBM treatment were reported. Mean PRBM cost of
healing was $1731. Use of PRBM was safe and effective for treatment of chronic
DFUs.
© 2022 The Authors. International Wound Journal published by
Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.13715
PMCID: PMC9284637
PMID: 35001559 [Indexed for MEDLINE]
Conflict of interest statement: David G. Armstrong, DPM, MD, PhD received
research funds from PERI to design and administrate the trial 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.
Robert D. 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 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. Jarrod P.
Kaufman MD received research funds to assist in study design and manuscript
preparation. 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 the LEIRT and his company received
research funds for enrolment in the clinical trial and write the paper for
publication. 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 Geistlich Pharma. IRB
conflict of interest statements are on file with PERI.
