PRINCETON, N.J.--(BUSINESS WIRE)--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.
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 proportion of subjects with complete wound closure (defined as complete re-epithelialization without drainage or need for dressings), and patients were treated until the earlier of wound closure or six weeks. To ensure that only non-closing wounds were treated, all wounds were at least four weeks old and all prospective study subjects participated in a two-week run-in period of SOC. Only those patients whose wounds did not close by 30% or more during the two-week period were enrolled in the study.
Highlights of the study’s findings include:
- 35% of subjects in the intent-to-treat AMNIOEXCEL® plus SOC cohort achieved complete wound closure at or before week six, compared with 0% of subjects in the intent-to-treat SOC alone cohort – these results are statistically significant (p=0.017)
- 45.5% of subjects in the per-protocol AMNIOEXCEL® plus SOC cohort achieved complete wound closure at or before week six, compared with 0% of subjects in the per-protocol SOC alone cohort – these results are statistically significant (p=0.0083)
- No treatment-related adverse events were reported in either cohort
The study was funded by Derma Sciences and the paper was authored by Robert J. Snyder, DPM; Kenneth Shimozaki, DPM; Arthur Tallis, DPM; Michael Kerzner, DPM; Alexander Reyzelman, DPM; Dimitrios Lintzeris, DO; Desmond Bell, DPM; Randi Rutan; and Barry Rosenblum, DPM.
This Level 1 published evidence supports the use of AMNIOEXCEL® for the treatment of non-closing diabetic foot ulcers.
Stephen T. Wills, Derma Sciences Executive Chairman and Interim Chief Executive Officer, said, “Most importantly, these results are great news for people suffering from chronic, hard-to-treat diabetic foot ulcers. In this well-designed and tightly administered study, patients treated with AMNIOEXCEL® along with standard of care had a far superior wound closure and a more rapid rate of wound closure than those treated with standard of care alone. These results are statistically significant and clinically meaningful, which is very important to health plan decision-makers in reviewing new coverage decisions. This study will enhance our efforts to gain positive coverage decisions from the remaining three Medicare Administrative Contractors who currently do not have a policy on AMNIOEXCEL® and require robust, evidence-based studies for their local coverage determinations."
Barry J. Wolfenson, Group President of Advanced Wound Care, commented, “Given the large proportion of people with type 1 or type 2 diabetes who will ultimately develop a foot ulcer, and the high rate of amputation associated with diabetic foot ulcers along with the mortality associated with these amputations, we are thrilled to share these exceptional data with the doctors and nurses who care for these patients on a daily basis. This should give clinicians high confidence in AMNIOEXCEL® as a clinically safe and efficacious product, offering them a viable, cost-effective solution.”
About the Trial Design and Findings
All subjects enrolled in this study received SOC throughout the trial, including the two-week run-in period. SOC included debridement of necrotic/non-viable tissue, moist wound dressings, off-loading and infection surveillance and management. Patients with chronic, diabetes-related wounds between 1 cm2 and 25 cm2 in area, which failed to close more than 30% in area during the two-week SOC run-in period, were randomly assigned 1:1 to receive AMNIOEXCEL® + SOC or SOC alone. Subjects in both groups returned to the clinic every week for dressing changes, wound inspection, debridement and dressing application. In these weekly assessments, the wounds also were photographed and measured. The primary endpoint of the study, complete closure of the ulcer without drainage or need for dressings, was assessed each week.
Of the 49 patients screened for participation, 29 were randomized with 15 allocated to the AMNIOEXCEL® + SOC group and 14 allocated to the SOC alone group. All randomized subjects were included in the intent to treat (ITT) analysis and the 21 subjects (11 AMNIOEXCEL® + SOC and 10 SOC) who completed the six-week trial were included in the per-protocol (PP) analysis. Subjects in the AMNIOEXCEL® + SOC group demonstrated a significantly greater closure rate than the SOC alone subjects, with 35% closure at six weeks in the AMNIOEXCEL® +SOC group vs. 0.0% closure in the SOC group in the ITT population (p=0.017), and 45.5% closure at six weeks in the AMNIOEXCEL® +SOC group vs. 0.0% closure in the SOC group in the PP population (p=0.0083).
The study was implemented at eight U.S. clinical sites.
About AMNIOEXCEL® Membrane
AMNIOEXCEL® Amniotic Allograft Membrane is a novel human placental-based tissue product. The membrane forms a protective covering over the wound while providing the key components found in human amnion including an intact ECM (extracellular matrix), cytokines and other growth factors. It easily integrates into the wound and helps provide the optimal environment to repair, reconstruct and replace wound tissue.
About Derma Sciences, Inc.
Derma Sciences is a tissue regeneration company focused on advanced wound and burn care. It offers a line of products with patented technologies to help better manage chronic and hard-to-heal wounds, many of which result from diabetes and poor vascular functioning. The Company sells AMNIOEXCEL® amniotic allograft membrane and AMNIOMATRIX® amniotic allograft suspension into the $500 million market for skin substitute products. TCC-EZ® is a gold-standard total contact casting system for diabetic foot ulcers. Derma Sciences’ MEDIHONEY® product line is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown in clinical studies to be effective in a variety of indications. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, and BIOGUARD® for barrier protection against microbes and other contaminants. The Company also offers a full product line of traditional dressings. For more information please visit www.dermasciences.com.
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