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

Caroline Fife, Jon T. Mader, Jeffery Stone, Leon Brill, Kathleen Satterfield, Andrea Norfleet, Amber Zwernemann, James T. Ryaby, Darrell H. Carney

Research output: Contribution to journalArticlepeer-review

39 Scopus citations

Abstract

Thrombin and thrombin peptides play a role in initiating tissue repair. The potential safety and efficacy of TP508 (Chrysalin®) treatment of diabetic foot ulcers was evaluated in a 60-subject, prospective, randomized, double-blind, placebo-controlled phase I/II clinical trial. Chrysalin® 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 μg Chrysalin® treatment resulted in 45 and 72% more subjects with complete healing than placebo treatment. Chrysalin® treatment of foot ulcers more than doubled the incidence of complete healing (p<0.05), increased mean closure rate ∼80% (p<0.05), and decreased the median time to 100% closure by ∼40% (p<0.05). Chrysalin® 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® for treatment of diabetic foot ulcers.

Original languageEnglish (US)
Pages (from-to)23-34
Number of pages12
JournalWound Repair and Regeneration
Volume15
Issue number1
DOIs
StatePublished - Jan 2007

ASJC Scopus subject areas

  • Surgery
  • Dermatology

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