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Oral Abstracts (Session 4 of 5)
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(Presentation 35.1) Results of a phase I, randomized, double-blind, placebo-controlled trial of topical rhVEGF (telbermin) for the treatment of diabetic foot ulcers Paul Kwon, MD; TJ Breen, PhD; S Gray, PhD; CJ Lynch, PhD; CP Semba, MD, Genentech, South San Francisco, Calif; JR Hanft, DPM, Doctor’s Research Network, South Miami, Fla; RA Pollak, DPM, MS, San Antonio Podiatry Associates, San Antonio, Tex; A Barbul, MD, FACS, Sinai Hospital of Baltimore, Baltimore, Md; C Van Gils, DPM, MS, IHC Dixie Regional Medical Center, St George, Utah Purpose: A phase I, randomized, double-blind, placebo-controlled trial was conducted to evaluate the safety, tolerability, and preliminary efficacy of topical rhVEGF (telbermin) as a treatment for diabetic neuropathic foot ulcers. Methods: Subjects received the study drug in conjunction with good wound care 3 times per week for up to 6 weeks, and there was a 6-week follow-up period. Subjects were monitored weekly by physical examination and planimetry of the ulcer. Fifty-five subjects from 9 US sites were randomized and treated (29 telbermin and 26 placebo). Results: Topical application of telbermin appeared to be safe and well tolerated. The incidence and intensity of adverse events were similar in the 2 treatment groups. The primary efficacy outcome measure was percent reduction (from baseline) in ulcer surface area at 6 weeks. Although the study did not meet the primary efficacy endpoint, positive trends were observed in the key efficacy endpoints. The median value for the telbermin group was 94.5% versus 85.3% for the placebo group (P = 0.67). The percentage of subjects with complete healing within 6 weeks was 41.4% in the telbermin group versus 26.9% in the placebo group (P = 0.39). In terms of time to complete healing, the rate (measured by the hazard ratio) was approximately 87% faster in the telbermin group, compared to the placebo group (P = 0.13). These analyses included all subjects who were randomized and received at least 1 dose of study drug. Conclusion: Based on the positive efficacy trends and given that no safety signals were observed, we believe that there is potential for topical telbermin as a treatment for diabetic foot ulcers, but further studies are needed. |
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