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Northern California Foot and Ankle Center Santa Rosa Enrolling Patients With Chronic Diabetic Foot Ulcers for Matrix Clinical Research Trial

Posted on: Wednesday, 12 March 2008, 06:00 CDT

SANTA ROSA, Calif., March 12 /PRNewswire/ -- Northern California Foot and Ankle Center Santa Rosa today announced it is recruiting patients with lower extremity diabetic foot ulcers to participate in the MATRIX clinical research trial. The MATRIX trial will study the effects of Excellarate(TM) (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 Walter F. D'Costa DPM, CWS, FCCWS, 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.

Northern California Foot and Ankle Center Santa Rosa is among an estimated 25 sites participating in the MATRIX trial. The trial is expected to enroll 210 patients nationwide. Prospective participants can call (707) 544-3337 for more information about the study and eligibility.

About Northern California Foot and Ankle Center Santa Rosa

Northern California Foot and Ankle Center Santa Rosa has been involved in the treatment of the Diabetic Extremity Wounds since 1980. Dr. Walter D'Costa was the past President of the Redwood Podiatric Medical Association and has a teaching appointment with the University of California San Francisco -- Santa Rosa Campus. He has lectured on the Diabetic Foot extensively over the years. He is the founder of the Department of Podiatric Medicine at Sutter Hospital and has served as Chair of the Department of Podiatric Medicine and Surgery and Credentials Committee. He was Chief of Staff Elect at Sutter Medical Center Santa Rosa.

Northern California Foot and Ankle Center Santa Rosa

CONTACT: Northern California Foot and Ankle Center Santa Rosa,+1-707-544-3337

Source: PRNewswire

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