title: Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity diabetic ulcers. Diabetic Ulcer Study Group.
abstract: 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.
authors: University of Pittsburgh, Presbyterian University Hospital, PA 15213.
authors: D L
authors: DL
authors: Steed
mesh_terms: 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
chemical_list: D010982:Platelet-Derived Growth Factor; D011994:Recombinant Proteins