Thrombin peptide Chrysalin((R)) stimulates healing of diabetic foot ulcers in a placebo-controlled phase I/II study

Thrombin and thrombin peptides play a role in initiating tissue repair. The potential safety and efficacy of TP508 (Chrysalin (R)) treatment of diabetic foot ulcers was evaluated in a 60-subject, prospective, randomized, double-blind, placebo-controlled phase I/II clinical trial. Chrysalin (R) in saline or saline alone was applied topically, twice weekly, to diabetic ulcers with standardized care and offloading. A dose-dependent effect was seen in the per-protocol population where 1 and 10 mu g Chrysalin (R) treatment resulted in 45 and 72% more subjects with complete healing than placebo treatment. Chrysalin (R) treatment of foot ulcers more than doubled the incidence of complete healing (p < 0.05), increased mean closure rate similar to 80% (p < 0.05), and decreased the median time to 100% closure by similar to 40% (p < 0.05). Chrysalin (R) treatment of heel ulcers within this population resulted in mean closure rates 165% higher than placebos (p < 0.02) and complete healing in 86% (6/7) of ulcers compared with 0% (0/5) of placebo ulcers (p < 0.03). Local wound reactions and adverse events (AEs) were equal between groups with no reported drug-related changes in laboratory tests or serious AEs. These results indicate the potential safety and efficacy of Chrysalin (R) for treatment of diabetic foot ulcers.