Cardium Begins Phase IIb Study of Excellarate

Cardium Therapeutics and its subsidiary Tissue Repair Co. have started recruitment for the Phase IIb MATRIX trial to evaluate the safety and efficacy of Excellarate for the treatment of nonhealing diabetic foot ulcers.

Excellarate is a DNA-based topical gel designed to be administered once or twice to stimulate wound healing.

The MATRIX study is a randomized, double-blind, placebo-controlled, comparator-arm trial, which will enroll approximately 210 patients who have Type I or II diabetes with a nonhealing foot ulcer.

The study’s primary endpoint is complete ulcer closure at 12 weeks or earlier. Secondary endpoints will be time to complete ulcer closure, change in ulcer area, durability of wound closure and safety and tolerance, Cardium said.