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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00351767 |
This is a Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of three different doses of topically applied telbermin in subjects ≥ 18 years old with diabetic foot ulcers. Approximately 160 adult subjects with Type 1 or Type 2 diabetes mellitus will be enrolled at approximately 40 investigational sites in the United States and Canada.
Condition | Intervention | Phase |
---|---|---|
Foot Ulcer, Diabetic |
Drug: placebo Drug: telbermin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Diabetic Foot Ulcers |
Enrollment: | 170 |
Study Start Date: | January 2006 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: telbermin
Topically applied
|
2: Experimental |
Drug: telbermin
Topically applied
|
3: Experimental |
Drug: telbermin
Topically applied
|
4: Placebo Comparator |
Drug: placebo
Topically applied
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | VGF3554g |
Study First Received: | July 11, 2006 |
Last Updated: | September 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00351767 |
Health Authority: | United States: Food and Drug Administration |
Diabetes Dabetic Feet |
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Diabetes Mellitus Vascular Diseases Endocrine System Diseases Endothelial Growth Factors |
Foot Diseases Diabetic Angiopathies Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Pathologic Processes Growth Substances Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |