Recombinant human platelet-derived growth factor-BB (becaplermin) for healing chronic lower extremity diabetic ulcers: an open-label clinical evaluation of efficacy

Wound Repair Regen. May-Jun 2000;8(3):162-8. doi: 10.1046/j.1524-475x.2000.00162.x.

Abstract

Topically applied recombinant human platelet-derived growth factor-BB (becaplermin) is a new pharmacologically active therapy for chronic, neuropathic, lower extremity diabetic ulcers. In previous studies, becaplermin gel was administered once daily but dressings were changed twice daily. In the present study of 134 patients with diabetes mellitus and full thickness lower extremity ulcers, dressings were changed only once per day, simplifying the treatment regimen. Efficacy criteria included the percentage of patients achieving complete healing within the 20-week treatment period, the time to achieve complete healing, the rate of ulcer recurrence during the 6-month period following healing, and treatment compliance. Complete healing of ulcers was achieved in 57. 5% of patients, with a mean time to closure of 63 days and a recurrence rate of 21% at 6 months. Of the potential factors affecting ulcer healing, only drug compliance (p < 0.001), dressing compliance (p < 0.01), the presence of infection (p < 0.01), baseline ulcer area (p < 0.05), and baseline total wound evaluation score (p < 0.05) were significantly associated with healing. Results of this study further confirm the efficacy and safety of becaplermin gel for the treatment of lower extremity diabetic ulcers.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Becaplermin
  • Chronic Disease
  • Diabetic Foot / drug therapy*
  • Gels
  • Humans
  • Platelet-Derived Growth Factor / administration & dosage
  • Platelet-Derived Growth Factor / therapeutic use*
  • Proto-Oncogene Proteins c-sis
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / therapeutic use*
  • Treatment Outcome
  • Wound Healing / drug effects*

Substances

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