Diabetic Neuropathy
Conditions
Keywords
Diabetes Mellitus, Neuropathy, Peripheral Artery Disease
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.
Interventions
BIOLOGICALVEGF
3 sets of injections, at 2 week intervals
Sponsors
Losordo, Douglas, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | 6 months |
Countries
United States
Outcome results
None listed