Journal article
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
International wound journal, v 21(4), pp e14882-e14882
Apr 2024
PMID: 38606794
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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.
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Details
- Title
- 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
- Creators
- David G Armstrong - University of Southern CaliforniaDennis P Orgill - Brigham and Women's HospitalRobert D Galiano - Northwestern UniversityPaul M Glat - St. Christopher's Hospital for ChildrenJarrod P Kaufman - McGowan Institute for Regenerative MedicineMarissa J Carter - Strategic Solutions ConsultingLawrence A DiDomenico - Lower Extremity Institute for Research and Therapy, Youngstown, Ohio, USACharles M Zelen - Professional Education and Research Institute
- Publication Details
- International wound journal, v 21(4), pp e14882-e14882
- Publisher
- Wiley
- Grant note
- 003 / Geistlich Pharma
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Web of Science ID
- WOS:001200552500001
- Scopus ID
- 2-s2.0-85190260679
- Other Identifier
- 991021868115504721
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InCites Highlights
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Dermatology
- Surgery