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February 1994

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

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.

Arch Surg. 1994;129(2):213-219. doi:10.1001/archsurg.1994.01420260109015

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)

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