ACell, Inc., a leading regenerative medicine company focused on the development, manufacturing and commercialization of tissue repair products, has announced it has initiated, with multiple patients enrolled, a U.S. post-market clinical trial (NCT01858545) comparing the efficacy of MatriStem® to a leading cellular scaffold, Dermagraft®, for the treatment of patients with diabetic foot ulcers (DFUs) that failed to adequately heal following initial standard of care therapy. The randomized, controlled trial will measure device efficacy, cost effectiveness and long-term ulcer recurrence, among other data points.
The single-blind, two-arm study will use independent evaluators to examine outcomes of diabetic foot ulcers treated with standard of care plus either MatriStem MicroMatrix (particles) and MatriStem Wound Matrix (sheets) - or Dermagraft.
The primary endpoint of the trial is the incidence of complete wound closure at eight weeks post-treatment, with secondary endpoints including rate of wound healing and quality of life assessment.
Adults with DFUs considered for treatment in the study must demonstrate an inadequate response to initial standard of care therapy and then will receive up to eight weeks of treatment with MatriStem or Dermagraft. With eight sites across the United States, the multi-center trial is expected to enroll a total of 102 patients.
Jim DeFrancesco, Chief Executive Officer and Board Director, said, "The initiation of our post-market, head-to-head study is a tremendous milestone for ACell as we hope to demonstrate the effectiveness of MatriStem devices in complete wound closure in patients with hard to treat diabetic foot ulcers. We look forward to completing enrollment of the trial, with the ultimate goal of broadening the use of MatriStem device solutions and expanding reimbursement for currently-approved devices to benefit a wider range of patients in need within the wound care setting."
One Principal Investigator said, "Following the lengthy screening process, we are excited to take the next step in the study as we believe there is an immediate need for a regenerative wound care therapy that completely repairs diabetic foot ulcers by restoring normal site-appropriate tissue where scarring would typically be expected and where competitive therapies have not been effective."
DFUs are open sores or ulcers on the feet that will not heal or keep returning in people with diabetes and can severely compromise a patient's quality of life. About 1.3 million people are afflicted with DFUs annually in the United States.