VEGF Gene Transfer for Diabetic Neuropathy

NCT00056290 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-11-11

No results posted yet for this study

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.

Conditions

  • Diabetic Neuropathy

Interventions

BIOLOGICAL

VEGF

3 sets of injections, at 2 week intervals

BIOLOGICAL

VEGF

3 sets of injections, at 2 week intervals

Sponsors & Collaborators

  • Losordo, Douglas, M.D.

    lead INDIV

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00056290 on ClinicalTrials.gov