VEGF Gene Transfer for Diabetic Neuropathy

November 10, 2010 updated by: Losordo, Douglas, M.D.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC
    • New York
      • New York, New York, United States, 10032
        • Columbia University Neuropathy Research Center, Neurological Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Losordo, Douglas, M.D.

Investigators

  • Principal Investigator: Allan H Ropper, M.D., Steward St. Elizabeth's Medical Center of Boston, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

March 10, 2003

First Submitted That Met QC Criteria

March 10, 2003

First Posted (Estimate)

March 11, 2003

Study Record Updates

Last Update Posted (Estimate)

November 11, 2010

Last Update Submitted That Met QC Criteria

November 10, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB-IND 11572
  • NIH #0104-467

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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