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 Feb;129(2):213-9. doi: 10.1001/archsurg.1994.01420260109015.

Abstract

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Aged
  • Becaplermin
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Life Tables
  • Male
  • Placebos
  • Platelet-Derived Growth Factor / administration & dosage
  • Platelet-Derived Growth Factor / therapeutic use*
  • Pressure Ulcer / drug therapy*
  • Pressure Ulcer / pathology
  • Prospective Studies
  • Proto-Oncogene Proteins c-sis
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / therapeutic use
  • Time Factors
  • Wound Healing

Substances

  • Placebos
  • Platelet-Derived Growth Factor
  • Proto-Oncogene Proteins c-sis
  • Recombinant Proteins
  • Becaplermin