The University Of Miami Is Enrolling Patients With Chronic Diabetic Foot Ulcers For MATRIX Clinical Trial

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 03 Dec 2007 - 3:00 PDT

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The University of Miami Department of Dermatology announced it is recruiting patients with lower extremity diabetic foot ulcers to participate in the MATRIX clinical trial. The MATRIX trial will study the effects of Excellarate™ (GAM501) (Ad5PDGF-B/bovine Type I collagen gel) for the potential treatment of patients with neuropathic non-healing diabetic foot ulcers. Excellarate is an investigational product designed to stimulate the process of wound healing.

The MATRIX (A Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers in the Lower Extremities) trial is a randomized, double-blind, placebo-controlled, comparator arm (standard of care) safety and efficacy study to evaluate GAM501 (Ad5PDGF-B/bovine Type I collagen gel) that is topically administered once or twice over the course of the study. The primary endpoint will be the effect of Excellarate on the incidence of complete ulcer closure at 12 weeks or earlier.

"The Excellarate topical gel using Gene Activated Matrix (GAM) technology is designed to provide localized and sustained cellular release of platelet-derived growth factor-BB protein (PDGF-BB). Sustained delivery of PDGF-BB directly at the wound site is believed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of chemotactic cells such as monocytes, fibroblasts, and endothelial cells, which are necessary for the stimulation of a variety of wound healing processes," stated Robert Kirsner, M.D., Ph.D., and a trial investigator.

There are currently more than 20 million Americans who have diabetes and this number is expected to double by the year 2030. Many diabetic patients suffer from peripheral neuropathy, or a loss of feeling in their feet, that puts them at increased risk of foot ulceration. Over 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 of the affected foot or leg.

The University of Miami is among an estimated 25 sites participating in the MATRIX trial. The trial is expected to enroll 210 patients nationwide. Prospective participants can call the University of Miami Department of Dermatology and speak with Aliette Espinosa at 305-547-4282 for more information about the study and eligibility.

University of Miami