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.
Prospective, randomized, double-blind trial.
Patients were treated in a nursing home or a hospital setting before transfer to a nursing home.
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).
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.
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.
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)
Mustoe TA, Cutler NR, Allman RM, Goode PS, Deuel TF, Prause JA, Bear M, Serdar CM, Pierce GF. A Phase II Study to Evaluate Recombinant Platelet-Derived Growth Factor-BB in the Treatment of Stage 3 and 4 Pressure Ulcers. Arch Surg. 1994;129(2):213-219. doi:10.1001/archsurg.1994.01420260109015