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

  1. Caroline Fife MD1,
  2. Jon T. Mader MD2,
  3. Jeffery Stone MD3,
  4. Leon Brill DPM3,
  5. Kathleen Satterfield DPM4,
  6. Andrea Norfleet PhD2,5,†,
  7. Amber Zwernemann BS2,
  8. James T. Ryaby PhD5,
  9. Darrell H. Carney PhD2

Article first published online: 23 JAN 2007

DOI: 10.1111/j.1524-475X.2006.00181.x

Issue

Wound Repair and Regeneration

Wound Repair and Regeneration

Volume 15, Issue 1, pages 23–34, January–February 2007

Additional Information

How to Cite

Fife, C., Mader, J. T., Stone, J., Brill, L., Satterfield, K., Norfleet, A., Zwernemann, A., Ryaby, J. T. and Carney, D. H. (2007), Thrombin peptide Chrysalin® stimulates healing of diabetic foot ulcers in a placebo-controlled phase I/II study. Wound Repair and Regeneration, 15: 23–34. doi: 10.1111/j.1524-475X.2006.00181.x

Author Information

  1. 1

    Department of Anesthesiology, University of Texas Health Science Center, Houston, Texas,

  2. 2

    Department of Biochemistry and Molecular Biology, University of Texas Medical Branch, Galveston, Texas,

  3. 3

    The Limb Salvage Center at the Brillstone Building, Dallas, Texas,

  4. 4

    University of Texas Health Science Center, Texas Diabetes Institute, San Antonio, Texas, and

  5. 5

    OrthoLogic Corp., Tempe, Arizona

  1. †

    *Dr. Norfleet's current address is: Genzyme Corporation, Cambridge, MA 02142.

*Reprint requests: Darrell H. Carney, PhD, Department of Biochemistry and Molecular Biology, The University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555-0645. Tel: +409 772 3210; Fax: 409-772-2880; Email: dcarney@utmb.edu

Publication History

  1. Issue published online: 23 JAN 2007
  2. Article first published online: 23 JAN 2007
  3. Manuscript received: January 31, 2006Accepted in final form: September 13, 2006

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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.

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