VEGF Gene Transfer for Diabetic Neuropathy

Phase 1

Completed

• Conditions: Diabetic Neuropathy
• Interventions: Biological: VEGF

• Registration Number: NCT00056290
• Lead Sponsor: Losordo, Douglas, M.D.

Brief Summary

This gene therapy study is being conducted to evaluate intramuscular gene transfer using VEGF (Vascular Endothelial Growth Factor) in patients with diabetic neuropathy in the legs. This condition causes a decrease in feeling and sensation due to diabetes. VEGF is DNA, or genetic material that is injected into the muscles of the leg. Once in the leg, it has been shown to cause new blood vessels to grow under a variety of conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2003-03-10
• Study First Submitted QC: 2003-03-10
• Study First Posted: 2003-03-11
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-10
• Last Update Posted: 2010-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	VEGF	VEGF
2	VEGF	Placebo

Primary Outcome Measures

Name	Time	Method
Safety	6 months

Trial Locations

Locations (2)

Columbia University Neuropathy Research Center, Neurological Institute; 🇺🇸 New York, New York, United States

Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC; 🇺🇸 Boston, Massachusetts, United States