A phase II study to evaluate recombinant platelet-derived growth factor-BB in the treatment of stage 3 and 4 pressure ulcers
T. A. Mustoe, N. R. Cutler, R. M. Allman, P. S. Goode, T. F. Deuel, J. A. Prause, M. Bear, C. M. Serdar and G. F. Pierce
Division of Plastic and Reconstructive Surgery, Northwestern Medical School, Chicago, Ill.
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 debrided 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 micrograms/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 micrograms/dL, and rPDGF-BB, 300 micrograms/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.
