500 Boylston Street, Boston, MA 02116 617-419-4700
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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.
Ages:21 and older
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.
Sponsor: Losordo, Douglas, M.D.
Phase: Phase 1/Phase 2
Trial ID: NCT00056290
Not Accepting Healthy Volunteers