The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial
| Autor: | Shawn Cazzell, Darrell L. Lange, Herbert B. Slade, Jaime E. Dickerson |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
business.industry Effective management Critical Care and Intensive Care Medicine medicine.disease Diabetic foot Small intestine submucosa law.invention Surgery Randomized controlled trial Standard care law Emergency Medicine medicine Adverse effect business Discovery Express |
| Zdroj: | Advances in Wound Care |
| ISSN: | 2162-1918 |
| Popis: | Objective: This study demonstrates that superior outcomes are possible when diabetic foot ulcers (DFU) are managed with tri-layer porcine small intestine submucosa (SIS). Approach: Patients with DFU from 11 centers participated in this prospective randomized controlled trial. Qualified subjects were randomized (1:1) to either SIS or standard care (SC) selected at the discretion of the Investigator and followed for 12 weeks or complete ulcer closure. Results: Eighty-two subjects (41 in each group) were evaluable in the intent-to-treat analysis. Ulcers managed with SIS had a significantly greater proportion closed by 12 weeks than for the Control group (54% vs. 32%, p=0.021) and this proportion was numerically higher at all visits. Time to closure for ulcers achieving closure was 2 weeks earlier for the SIS group than for SC. Median reduction in ulcer area was significantly greater for SIS at each weekly visit (all p values |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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