A Phase II Study to Evaluate Recombinant Platelet-Derived Growth Factor-BB in the Treatment of Stage 3 and 4 Pressure Ulcers

Abstract

Objective: To determine the efficacy of the daily topical application of recombinant platelet-derived growth factor—BB (rPDGF-BB), a recognized vulnerary agent, in the treatment of deep pressure ulcers. Design: Prospective, randomized, double-blind trial. Setting: Patients were treated in a nursing home or a hospital setting before transfer to a nursing home. Patients: Eligibility criteria included a clean pressure ulcer that had been adequately débrided and the absence of severe cardiac, pulmonary, or renal conditions. The causes of the ulcers were not related to a venous or arterial vascular disorder. The patients were elderly (mean age, 68 to 74 years). Interventions: After randomization, patients were given daily topical aqueous rPDGF-BB (dosage, 100 or 300 μg/mL) or placebo and saline gauze dressings were applied daily in addition to frequent turning. Main Outcome Measure: Serial volume measurements of the healing wounds were taken using alginate molds. Results: The ulcers of 41 patients were analyzed. At the end of 28 days, median ulcer volumes had decreased to 83%, 29%, and 40% of the initial size in the groups receiving placebo, rPDGF-BB, 100 μg/dL, and rPDGF-BB, 300 μg/mL, respectively. When adjusted for initial volume, ulcer volume after 28 days of treatment was smaller in the rPDGF-BB—treated groups compared with the placebo group (analysis of covariance, P=.056). Ulcers in the two rPDGF-BB—treated groups were significantly smaller in volume compared with those in the placebo group, using a linear contrast procedure. Conclusions: Data from this small trial suggest that local application of rPDGF-BB may be of therapeutic benefit in accelerating the healing of chronic pressure ulcers. (Arch Surg. 1994;129:213-219)