VEGF Gene Transfer for Diabetic Neuropathy

NCT ID: NCT00056290

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Neuropathy

Keywords

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Diabetes Mellitus Neuropathy Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

VEGF

Group Type ACTIVE_COMPARATOR

VEGF

Intervention Type BIOLOGICAL

3 sets of injections, at 2 week intervals

2

Placebo

Group Type PLACEBO_COMPARATOR

VEGF

Intervention Type BIOLOGICAL

3 sets of injections, at 2 week intervals

Interventions

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VEGF

3 sets of injections, at 2 week intervals

Intervention Type BIOLOGICAL

VEGF

3 sets of injections, at 2 week intervals

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Losordo, Douglas, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Northwestern University, Northwestern Memorial Hospital

Principal Investigators

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Allan H Ropper, M.D.

Role: PRINCIPAL_INVESTIGATOR

Steward St. Elizabeth's Medical Center of Boston, Inc.

Locations

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Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC

Boston, Massachusetts, United States

Site Status

Columbia University Neuropathy Research Center, Neurological Institute

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.semc.org

Caritas St. Elizabeth's Medical Center of Boston

Other Identifiers

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NIH #0104-467

Identifier Type: -

Identifier Source: secondary_id

BB-IND 11572

Identifier Type: -

Identifier Source: org_study_id