Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity diabetic ulcers. Diabetic Ulcer Study Group

J Vasc Surg. 1995 Jan;21(1):71-8; discussion 79-81. doi: 10.1016/s0741-5214(95)70245-8.

Abstract

Purpose: The purpose of this study was to investigate the efficacy and safety of recombinant human platelet-derived growth factor (rhPDGF-BB) in a double-blind, placebo-controlled, multicenter study of patients with chronic diabetic ulcers.

Methods: Patients with chronic, full-thickness, lower-extremity diabetic neurotrophic ulcers of at least 8 weeks' duration, free of necrotic and infected tissue after debridement, and with transcutaneous oxygen tensions of 30 mm Hg or greater were studied. A total of 118 patients were randomized to receive either topical rhPDGF-BB (2.2 micrograms/cm2 of ulcer area) or placebo until the ulcer was completely resurfaced or for a maximum of 20 weeks, whichever occurred first.

Results: Twenty-nine (48%) of 61 patients randomized to the rhPDGF-BB group achieved complete wound healing during the study compared with only 14 (25%) of 57 patients randomized to the placebo group (p = 0.01). The median reduction in wound area in the group given rhPDGF-BB was 98.8% compared with 82.1% in the group given placebo (p = 0.09). There were no significant differences in the incidence or severity of adverse events between the rhPDGF-BB and placebo groups.

Conclusions: Once-daily topical application of rhPDGF-BB is safe and effective in stimulating the healing of chronic, full-thickness, lower-extremity diabetic neurotrophic ulcers.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Chronic Disease
  • Diabetic Neuropathies / complications*
  • Double-Blind Method
  • Female
  • Humans
  • Leg Ulcer / etiology
  • Leg Ulcer / pathology
  • Leg Ulcer / therapy*
  • Male
  • Middle Aged
  • Platelet-Derived Growth Factor / administration & dosage
  • Platelet-Derived Growth Factor / adverse effects
  • Platelet-Derived Growth Factor / therapeutic use*
  • Recombinant Proteins / therapeutic use
  • Wound Healing

Substances

  • Platelet-Derived Growth Factor
  • Recombinant Proteins