Village Podiatry Group’s Clinical Research Division in Smyrna is conducting the MATRIX clinical trial studying the effects of a new product, Excellarate, for potential treatment of non-healing diabetic wounds. Brent Nixon, DPM is the principal investigator of this Phase IIb trial. The MATRIX study is being conducted by Cardium Therapeutics at 25 U.S. sites including Johns Hopkins Medical Center and New York Presbyterian Hospital.
More than 850,000 chronic diabetic ulcers are diagnosed in the U.S. each year. Patients with non-healing ulcers are more susceptible to infections that may lead to amputation. The MATRIX trial is a randomized, double-blind safety and efficacy trial in which Excellarate is topically administered once or twice over the course of the study, with a goal of complete ulcer closure at 12 weeks or earlier. To qualify, patients must be diagnosed with Type I or II Diabetes with a non-healing foot ulcer present for at least six weeks.
“The Excellarate topical gel, using Gene Activated Matrix (GAM) technology is designed to provide release of the platelet-derived growth factor BB protein, which stimulates the growth of new blood vessels and granulation tissue formation, the building blocks for a variety of wound healing processes,” said Dr. Nixon. “The study’s goal is to heal ulcers before they develop into serious limb infections putting patients at risk of amputation.”