A randomised, phase I/II, double-blind, placebo-controlled study was designed to assess the effect of topically applied recombinant human BB homodimeric platelet-derived growth factor (rPDGF-BB) on healing of chronic pressure ulcers. Twenty patients were randomly allocated daily treatment for 28 days with 1, 10, or 100 μg/ml rPDGF-BB (0·01, 0·1, or 1·0 μg per cm2 ulcer area) or placebo. Patients treated with 100 μg/ml rPDG F-BB showed a greater healing response than the placebo group, but the lower doses had little effect. After 28 days, ulcers treated with 100 μg/ml rPDGF-BB were smaller than those treated with placebo (mean [SE] volume 6·4 [4·0] vs 21·8 [5·6]% of day 0 volume). There were no toxic effects. These preliminary findings suggest that rPDGF-BB is a potent wound-healing agent in soft tissue.
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