PMID- 35001559 OWN - NLM STAT- MEDLINE DCOM- 20220718 LR - 20220720 IS - 1742-481X (Electronic) IS - 1742-4801 (Print) IS - 1742-4801 (Linking) VI - 19 IP - 5 DP - 2022 Aug TI - 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. PG - 1197-1209 LID - 10.1111/iwj.13715 [doi] AB - 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. CI - (c) 2022 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd. FAU - Armstrong, David G AU - Armstrong DG AUID- ORCID: 0000-0003-1887-9175 AD - Division of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA. FAU - Orgill, Dennis P AU - Orgill DP AUID- ORCID: 0000-0002-8279-7310 AD - Professional Education and Research Institute, Roanoke, Virginia, USA. FAU - Galiano, Robert D AU - Galiano RD AUID- ORCID: 0000-0001-9552-6483 AD - Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA. FAU - Glat, Paul M AU - Glat PM AUID- ORCID: 0000-0002-5009-8603 AD - Surgery and Pediatrics, Drexel University College of Medicine, St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, USA. FAU - Kaufman, Jarrod P AU - Kaufman JP AUID- ORCID: 0000-0001-7967-8612 AD - Department of Surgery, Temple University School of Medicine and McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. FAU - Carter, Marissa J AU - Carter MJ AUID- ORCID: 0000-0002-2265-6639 AD - Strategic Solutions, Inc., Bozeman, Montana, USA. FAU - DiDomenico, Lawrence A AU - DiDomenico LA AD - Lower Extremity Institute for Research and Therapy, Youngstown, Ohio, USA. FAU - Zelen, Charles M AU - Zelen CM AUID- ORCID: 0000-0001-5682-7056 AD - Professional Education and Research Institute, Roanoke, Virginia, USA. LA - eng GR - 002/Geistlich Pharma/ PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20220109 PL - England TA - Int Wound J JT - International wound journal JID - 101230907 SB - IM MH - *Diabetes Mellitus MH - *Diabetic Foot/therapy MH - Humans MH - Pilot Projects MH - Prospective Studies MH - Quality of Life MH - Standard of Care MH - Treatment Outcome PMC - PMC9284637 OTO - NOTNLM OT - advanced wound care OT - advanced wound matrix OT - diabetic foot ulcers OT - standard of care OT - wound healing COIS- 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. EDAT- 2022/01/11 06:00 MHDA- 2022/07/19 06:00 PMCR- 2022/01/09 CRDT- 2022/01/10 06:55 PHST- 2021/10/14 00:00 [revised] PHST- 2021/07/23 00:00 [received] PHST- 2021/10/20 00:00 [accepted] PHST- 2022/01/11 06:00 [pubmed] PHST- 2022/07/19 06:00 [medline] PHST- 2022/01/10 06:55 [entrez] PHST- 2022/01/09 00:00 [pmc-release] AID - IWJ13715 [pii] AID - 10.1111/iwj.13715 [doi] PST - ppublish SO - Int Wound J. 2022 Aug;19(5):1197-1209. doi: 10.1111/iwj.13715. Epub 2022 Jan 9.