A PHASE-II STUDY TO EVALUATE RECOMBINANT PLATELET-DERIVED GROWTH FACTOR-BB IN THE TREATMENT OF STAGE-3 AND STAGE-4 PRESSURE ULCERS

Objective: To determine the efficacy of the daily topical application of recombinant platelet-derived growth factor-BB (rPDGF-BB), a recogni zed vulnerary agent, in the treatment of deep pressure ulcers. Design: Prospective, randomized, double-blind trial. Setting: Patients were t reated in a nursing home or a hospital setting before transfer to a nu rsing home. Patients: Eligibility criteria included a clean pressure u lcer that had been adequately debrided and the absence of severe cardi ac, pulmonary, or renal conditions. The causes of the ulcers were not related to a venous or arterial vascular disorder. The patients were e lderly (mean age, 68 to 74 years). Interventions: After randomization, patients were given daily topical aqueous rPDGF-BB (dosage, 100 or 30 0 mu g/ mt) or placebo and saline gauze dressings were applied daily i n addition to frequent turning. Main Outcome Measure: Serial volume me asurements of the healing wounds were taken using alginate molds. Resu lts: The ulcers of 41 patients were analyzed. At the end of 28 days, m edian ulcer volumes had decreased to 83%, 29%, and 40% of the initial size in the groups receiving placebo, rPDGF-BB, 100 mu g/dL, and rPDGF -BB, 300 mu g/mL, respectively. When adjusted for initial volume, ulce r volume after 28 days of treatment was smaller in the rPDGF-BB-treate d groups compared with the placebo group (analysis of covariance, P=.0 56). Ulcers in the two rPDGF-BB-treated groups were significantly smal ler in volume compared with those in the placebo group, using a linear contrast procedure. Conclusions: Data from this small trial suggest t hat local application of rPDGF-BB may be of therapeutic benefit in acc elerating the healing of chronic pressure ulcers.