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Multicenter RCT demonstrates AMNIOEXCEL® + SOC significantly increases the closure of chronic Diabetic Foot Ulcers

Multicenter RCT demonstrates AMNIOEXCEL® + SOC significantly increases the closure of chronic Diabetic Foot Ulcers

RCT demonstrates AMNIOEXCEL® + SOC significantly increases the closure of chronic Diabetic Foot Ulcers

Findings from Multicenter Study Comparing Derma Sciences’ AMNIOEXCEL® Against Standard-of-Care for Treating Diabetic Foot Ulcers Published in WOUNDS, a Leading Peer-Reviewed Journal

AmnioExcel RCT
Princeton, New Jersey

Derma Sciences, Inc. (Nasdaq:DSCI), a tissue regeneration company focused on advanced wound and burn care, announces that a peer-reviewed comparative clinical study of AMNIOEXCEL® Amniotic Allograft Membrane plus standard-of-care (SOC), compared with SOC alone, for the closure of hard-to-treat diabetic foot ulcers, has been published. The results are statistically significant and clinically meaningful, with the closure rate at six weeks in the AMNIOEXCEL® plus SOC treatment arm far exceeding the SOC alone treatment arm.

The study, “A Prospective, Randomized, Controlled, Multicenter Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcers,” was published in the peer-reviewed journal WOUNDS. The Early View electronic publication of the study is now available here and the publication is expected to follow in the March 2016 print issue of the journal.

  • Data from new study show 45.5% of subjects treated per protocol with AMNIOEXCEL® plus standard of care achieved complete wound closure by six weeks, while 0% of subjects treated with standard-of-care alone achieved complete wound closure
  • Findings will enhance efforts to gain positive coverage decisions from three remaining Medicare Administrative Contractors

The study analyzed data from 29 patients enrolled in a prospective, randomized, controlled, multicenter clinical trial and showed that AMNIOEXCEL® plus SOC is superior to SOC alone. The endpoint was the ...read more.