Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study.
OBJECTIVE
To compare the efficacy and safety of topically applied recombinant human platelet-derived growth factor-BB (rhPDGF-BB) (becaplermin) with placebo gel in patients with chronic diabetic neuropathic ulcers of the lower extremities.


METHODS
This multicenter double-blind placebo-controlled phase III trial included 382 patients with type 1 or type 2 diabetes and chronic ulcers of at least 8 weeks' duration. After sharp debridement of the ulcer, patients were randomized to receive becaplermin gel 30 micrograms/g, becaplermin gel 100 micrograms/g, or placebo gel, in conjunction with a standardized regimen of good wound care until complete wound closure was achieved or for a maximum of 20 weeks. Moist saline-soaked gauze dressings were changed twice daily with study medication applied by patients or caregivers at the evening dressing change. Safety was assessed by monitoring adverse events (AEs) and by clinical laboratory evaluations.


RESULTS
Compared with placebo gel, becaplermin gel 100 micrograms/g significantly increased the incidence of complete wound closure by 43% (50 vs. 35%, P = 0.007) and decreased the time to achieve complete wound closure by 32% (86 vs. 127 days; estimated 35th percentile, P = 0.013). AEs reported during treatment or during a 3-month follow-up period were similar in nature and incidence across all treatment groups.


CONCLUSIONS
Becaplermin gel 100 micrograms/g, in conjunction with good wound care, significantly increased the incidence of complete wound closure and significantly reduced the time to complete closure of chronic diabetic neuropathic ulcers. The safety profile of becaplermin gel was similar to that of placebo gel.
Wieman
T J
TJ
Department of Surgery, University of Louisville School of Medicine, Kentucky, USA.
Smiell
J M
JM
Su
Y
Y
D000287:Administration, Topical; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000077214:Becaplermin; D002908:Chronic Disease; D003710:Demography; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D017719:Diabetic Foot / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D010982:Platelet-Derived Growth Factor / Q000009:adverse effects / Q000627:therapeutic use*; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012016:Reference Values; D016896:Treatment Outcome
D000925:Anticoagulants; D005782:Gels; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins; D000077214:Becaplermin