Armstrong DG, Orgill DP, Galiano RD, Glat PM, Kaufman JP, Carter MJ, DiDomenico LA, Zelen CM, et al.
International wound journal. Date of publication 2024 Apr 1;volume 21(4):e14882.
1. Int Wound J. 2024 Apr;21(4):e14882. doi: 10.1111/iwj.14882.
A purified reconstituted bilayer matrix shows improved outcomes in treatment of
non-healing diabetic foot ulcers when compared to the standard of care: Final
results and analysis of a prospective, randomized, 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(8).
Author information:
(1)Division of Surgery, Keck School of Medicine, University of Southern
California, Los Angeles, California, USA.
(2)Division of Plastic Surgery, Brigham and Women's Hospital, Boston,
Massachusetts, 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.
(8)Professional Education and Research Institute, Roanoke, Virginia, USA.
As the incidence of diabetic foot ulcers (DFU) increases, better treatments that
improve healing should reduce complications of these ulcers including infections
and amputations. We conducted a randomized controlled trial comparing outcomes
between a novel purified reconstituted bilayer membrane (PRBM) to the standard
of care (SOC) in the treatment of non-healing DFUs. This study included 105
patients who were randomized to either of two treatment groups (n = 54 PRBM;
n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study
per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the
percentage of wounds closed after 12 weeks. Secondary outcomes included percent
area reduction, time to healing, quality of life, and cost to closure. The DFUs
that had been treated with PRBM healed at a higher rate than those treated with
SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated
with PRBM also healed significantly faster than those treated with SOC with a
mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area
reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no
adverse events or serious adverse events that were related to either the PRBM or
the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM.
Thus, the use of this PRBM is an effective option for the treatment of chronic
DFUs.
© 2024 The Authors. International Wound Journal published by
Medicalhelplines.com Inc and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.14882
PMCID: PMC11010253
PMID: 38606794 [Indexed for MEDLINE]
Conflict of interest statement: David 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 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. Jarrod Kauffman MD received research funds to assist in study
design and in manuscript preparation. Marissa Carter, PhD received research
funds to provide the statistical analysis plan, provide the statistical analysis
for this trial and assist with writing the result section of the manuscript.
Lawrence Didomenico, DPM is the medical director of the LEIRT and his company
received research funds for enrollment 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 relation to this study, or with regard to Geistlich Pharma. IRB
conflict of interest statements are on file with PERI.
