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p.VGI.1 (VEGF2) Gene Transfer for Diabetic Neuropathy

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Trial Conditions
  • Diabetic Neuropathy
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
21 and older

Gender:
Both

Eligibility

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.

Gender: Both
Steward Physician(s)
  • Allan H Ropper, M.D.
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Biological
  • VEGF
  • VEGF
Physician Researcher

Investigator Name:

  • Allan H Ropper, M.D.

Other Information

Sponsor: Losordo, Douglas, M.D.
Phase: Phase 1/Phase 2
Trial ID: NCT00056290
Volunteers:  Not Accepting Healthy Volunteers

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