Northern California Foot and Ankle Center initiates diabetic foot ulcer trial

The Matrix trial is a randomized, double-blind, placebo-controlled, comparator arm (standard of care) safety and efficacy study to evaluate Excellarate (GAM501) 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 Matrix trial will study the effects of GAM501 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. Northern California Foot and Ankle Center Santa Rosa is among an estimated 25 sites participating in the Matrix trial, which is expected to enroll 210 patients nationwide.

Walter D’Costa, trial investigator, said: “The Excellarate topical gel using Gene Activated Matrix technology is designed to provide localized and sustained cellular release of platelet-derived growth factor-BB protein. 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.”