Premium
Thrombin peptide Chrysalin ® stimulates healing of diabetic foot ulcers in a placebo‐controlled phase I/II study
Author(s) -
Fife Caroline,
Mader Jon T.,
Stone Jeffery,
Brill Leon,
Satterfield Kathleen,
Norfleet Andrea,
Zwernemann Amber,
Ryaby James T.,
Carney Darrell H.
Publication year - 2007
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1524-475x.2006.00181.x
Subject(s) - medicine , placebo , saline , adverse effect , wound healing , diabetes mellitus , population , diabetic foot , heel , surgery , incidence (geometry) , randomized controlled trial , clinical trial , anesthesia , gastroenterology , pathology , endocrinology , physics , alternative medicine , environmental health , optics , anatomy
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.