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

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.

• Authors: D L Steed
• Journal: Journal of vascular surgery (J Vasc Surg) Vol. 21 Issue 1 Pg. 71-8; discussion 79-81 (Jan 1995) ISSN: 0741-5214 [Print] United States
• PMID: 7823364 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Platelet-Derived Growth Factor
• Recombinant Proteins

Topics

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