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Article |

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. doi:10.1001/archsurg.1994.01420260109015.
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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)


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