Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity diabetic ulcers. Diabetic Ulcer Study Group.
OBJECTIVE
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.
Steed
D L
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University of Pittsburgh, Presbyterian University Hospital, PA 15213.
D000287:Administration, Topical; D002908:Chronic Disease; D003929:Diabetic Neuropathies / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000209:etiology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010982:Platelet-Derived Growth Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D014945:Wound Healing
D010982:Platelet-Derived Growth Factor; D011994:Recombinant Proteins