Biomaterials company MiMedx Group, Inc. an integrated developer, manufacturer and marketer of products processed from human amniotic membrane, has announced that a randomized controlled trial for the Company’s EpiFix® wound care allograft has been published in the International Wound Journal.
Included in the IRB-approved, prospective, randomized, single-center clinical trial were patients with a diabetic foot ulcer of at least 4-week duration without infection having adequate arterial perfusion. Patients were randomized to receive standard care alone or standard care with the addition of EpiFix®. Wound size reduction and rates of complete healing after 4 and 6 weeks were evaluated. After 4 and 6 weeks of treatment, the overall healing rate with application of EpiFix® was shown to be 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds, respectively. Patients treated with EpiFix® achieved superior healing rates over standard treatment alone. The company says these results show that using EpiFix® in addition to standard care is efficacious for wound healing.
In a separate, “crossover” study, patients receiving “standard of care” treatment were given the chance to have EpiFix® applied. Results of that study will be published shortly, having been accepted for publication.
Parker H. “Pete” Petit, Chairman and CEO, said, “The results of this clinical trial were compelling. The allografts were so clinically effective that extremely high statistical significance was reached quickly, and the study was concluded early. This adds to our series of publications that chronicle the clinical and cost effectiveness of our PURION® processed allografts. We expect the results of several additional clinical and scientific studies to be released in the next few months.”
Bill Taylor, President and COO, commented, “When our study data is compared to a published RCT of a major competitor’s product, EpiFix® brought wound closure to approximately three times more patients in half the time. EpiFix® also has size appropriate grafts to fit the wound area with very little waste, making EpiFix® much more cost-effective overall.”
Source: MiMedx Group, Inc.