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
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Le résumé fourni par la source
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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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 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
- Date Crossref
- 01/04/2024
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Southern California Division of Surgery pays non établi dans la noticeUniversité ou école supérieure
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Brigham and Women's Hospital Division of Plastic Surgery pays non établi dans la noticeÉtablissement de santé
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Northwestern University Division of Plastic Surgery pays non établi dans la noticeUniversité ou école supérieure
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St. Christopher's Hospital for Children pays non établi dans la noticeÉtablissement de santé
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Drexel University Surgery and Pediatrics pays non établi dans la noticeUniversité ou école supérieure
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University of Pittsburgh Department of Surgery pays non établi dans la noticeUniversité ou école supérieure
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McGowan Institute for Regenerative Medicine Department of Surgery pays non établi dans la noticeStructure de recherche
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Temple University pays non établi dans la noticeUniversité ou école supérieure
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Strategic Solutions Consulting (United States) pays non établi dans la noticeEntreprise
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Professional Education and Research Institute pays non établi dans la noticeStructure de recherche
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Keck School of Medicine Division of Surgery pays non établi dans la noticeUniversité ou école supérieure
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Feinberg School of Medicine Division of Plastic Surgery pays non établi dans la noticeUniversité ou école supérieure
Division of Surgery — University of Southern California, Division of Plastic Surgery — Brigham and Women's Hospital et Division of Plastic Surgery — Northwestern University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.