VEGF Gene Transfer for Diabetic Neuropathy

Losordo, Douglas, M.D.

Status and phase

Completed

Phase 2

Phase 1

Conditions

Diabetic Neuropathy

Treatments

Biological: VEGF

Study type

Interventional

Identifiers

NCT00056290

BB-IND 11572

NIH #0104-467

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

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.

Exclusion criteria

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.