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Thrombin peptide Chrysalin((R)) stimulates healing of diabetic foot ulcers in a placebo-controlled phase I/II study. Wound Repair Regen. 2007 Jan-Feb;15(1):23-34
Fife C, Mader JT, Stone J, Brill L, Satterfield K, Norfleet A, Zwernemann A, Ryaby JT, Carney DH
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 mug 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 approximately 80% (p<0.05), and decreased the median time to 100% closure by approximately 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.
Why do drug companies insist on testing new wound products insist on testing them against a treatment method (ie saline) that nobody uses? Of course the new product will be better. Why not test it against the most common type of wound therapy used?