[HTML][HTML] Clinical evaluation of recombinant human platelet–derived growth factor for the treatment of lower extremity diabetic ulcers
DL Steed - Journal of vascular surgery, 1995 - Elsevier
DL Steed
Journal of vascular surgery, 1995•ElsevierPurpose: 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 …
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 …
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 μg/cm 2 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. (J VASC SURG 1995;21:71-81.)
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