A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for Induction of Healing of Diabetic Foot Ulcers
Summary
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Foot Ulcer, Diabetic
Intervention
placebo, telbermin
Status
Completed
Source
Genentech
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00351767
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Diabetic Foot
Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.
Foot Ulcer
Lesion on the surface of the skin of the foot, usually accompanied by inflammation. The lesion may become infected or necrotic and is frequently associated with diabetes or leprosy.
Diabetic Neuropathies
Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)
Foot Deformities, Acquired
Distortion or disfigurement of the foot, or a part of the foot, acquired through disease or injury after birth.
Duodenal Ulcer
A PEPTIC ULCER located in the DUODENUM.
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