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A Phase II Study to Evaluate Recombinant Platelet-Derived Growth Factor-BB in the Treatment of Stage 3 and 4 Pressure Ulcers
Thomas A. Mustoe, MD;
Neal R. Cutler, MD;
Richard M. Allman, MD;
Patricia S. Goode, MD;
Thomas F. Deuel, MD;
Jo Ann Prause, PhD;
Moraye Bear, MS, MA;
Cuneyt M. Serdar, PhD;
Glenn F. Pierce, PhD, MD
Arch Surg. 1994;129(2):213-219.
Abstract
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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)
Author Affiliations
From the Division of Plastic and Reconstructive Surgery, Northwestern Medical School, Chicago, Ill (Dr Mustoe); California Clinical Trials, Beverly Hills (Dr Cutler); the Center for Aging and Division of Gerontology and Geriatric Medicine, Department of Veterans Affairs Medical Center, University of Alabama at Birmingham (Drs Allman and Goode); Division of Hematology, the Departments of Medicine, Biochemistry, and Molecular Biophysics, The Jewish Hospital, Washington University School of Medicine, St Louis, Mo (Dr Deuel); and the Departments of Biometrics (Drs Prause and Bear), Product Development (Dr Serdar), and Experimental Pathology (Dr Pierce), Amgen Inc, Thousand Oaks, Calif.
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