VEGF Gene Transfer for Diabetic Neuropathy

Completed · Phase 1/Phase 2

Conditions studied: Diabetic Neuropathy

In brief

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.

Key facts

Study ID

NCT00056290

Run by

Losordo, Douglas, M.D.

People needed

60

Starts

2002-12-01

Expected to finish

2008-04-01

Last updated by the study team

2010-11-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible to enroll and remain in the study, patients must meet the following criteria:
• Be at least 21 years old.
• Have type I or type II diabetes mellitus and require oral anti-hyperglycemic agents or insulin.
• Have peripheral neuropathy related to diabetes.

You may not qualify if…

• Patients are to be excluded from the trial if any of the following conditions are met:
• Have a history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
• Be unable to meet study requirements, including approximately 7-9 out-patient visits over a 12 month period.

Where it is running

• Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC — Boston, Massachusetts, United States
• Columbia University Neuropathy Research Center, Neurological Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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