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

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 pre...

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Bibliographic Details
Published in:Wound repair and regeneration 2000-05, Vol.8 (3), p.162-168
Main Authors: Embil, John M, Papp, Kim, Sibbald, Gary, Tousignant, Jacqueline, Smiell, Janice M, Wong, Betty, Lau, Cathy Y
Format: Article
Language:English
Subjects:
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
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Summary: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.
ISSN:1067-1927
1524-475X
DOI:10.1046/j.1524-475x.2000.00162.x