VEGF Gene Transfer for Diabetic Neuropathy

Sponsor

Losordo, Douglas, M.D. (Other)

Overall Status

Completed

CT.gov ID

NCT00056290

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathy	Biological: VEGF Biological: VEGF	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2002

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 VEGF	Biological: VEGF 3 sets of injections, at 2 week intervals
Placebo Comparator: 2 Placebo	Biological: VEGF 3 sets of injections, at 2 week intervals

Arm

Intervention/Treatment

Active Comparator: 1

VEGF

Biological: VEGF

3 sets of injections, at 2 week intervals

Placebo Comparator: 2

Placebo

Biological: VEGF

3 sets of injections, at 2 week intervals

Outcome Measures

Primary Outcome Measures

Safety [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC	Boston	Massachusetts	United States	02135
2	Columbia University Neuropathy Research Center, Neurological Institute	New York	New York	United States	10032