A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
This is a Phase I, double blind, randomized, placebo-controlled study that will enroll approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic foot ulcers. The study will be conducted at approximately 12 investigational sites in the United States.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||An Exploratory, Double-Blind, Randomized, Placebo Controlled Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers|
- Incidence of clinically significant hypotension.
- Incidence of clinically significant ulcer infection defined by increased discharge and malodorous exudates from the ulcer, fever, and a white blood cell (WBC) count of >10,000/uL
- Development of anti telbermin antibodies
- Incidence of adverse events
- Percent reduction in total ulcer surface area.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069446
|Study Director:||Tim Breen, Ph.D.||Genentech|