title: The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial.
abstract: 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 (allpvalues<0.05). Review of reported adverse events found no safety concerns.Innovation:These data support the use of tri-layer SIS for the effective management of DFU.Conclusion:In this randomized controlled trial, SIS was found to be associated with more rapid improvement, and a higher likelihood of achieving complete ulcer closure than those ulcers treated with SC.
authors.affiliation: Valley Vascular Surgery Associates of Fresno , Fresno, California. ; Limb Preservation Platform, Inc. , Fresno, California. ; Division of Podiatry, Department of Surgery, University of California , San Francisco, San Francisco, California.
authors.forename: Shawn M
authors.initials: SM
authors.lastname: Cazzell
authors.affiliation: Smith and Nephew, Inc. , Fort Worth, Texas.
authors.forename: Darrell L
authors.initials: DL
authors.lastname: Lange
authors.affiliation: Smith and Nephew, Inc. , Fort Worth, Texas. ; Department of Immunology and Cell Biology, University of North Texas Health Science Center , Fort Worth, Texas.
authors.forename: Jaime E
authors.initials: JE
authors.lastname: Dickerson
authors.affiliation: Smith and Nephew, Inc. , Fort Worth, Texas. ; Department of Pediatrics, University of North Texas Health Science Center , Fort Worth, Texas.
authors.forename: Herbert B
authors.initials: HB
authors.lastname: Slade