VEGF Gene Transfer for Critical Limb Ischemia

October 18, 2010 updated by: Losordo, Douglas, M.D.

The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to high-risk Critical Limb Ischemia (a condition in which there is poor blood circulation in the leg). This trial will assess whether VEGF improves rest pain and/or heals ulcers in the legs of patients with peripheral artery disease (blockages in leg arteries.)

VEGF is DNA, or genetic material that will be injected into the leg muscles on three separate occasions, each 2 weeks apart. Once the DNA is in the leg, it directs the cells of the artery wall to increase its production of VEGF, which has been shown to cause new blood vessels to grow. This experimental therapy is designed to grow new blood vessels around blockages in the leg arteries.

The total length of participation in this study is approximately 1 year and will require approximately 8 clinic visits within that year. Following enrollment in the study, testing may be done for cancer screening, blood work, physical exams, vascular testing and eye exams. There is no charge for any testing or office visits required by the study.

This study has been approved by the Food and Drug Administration (FDA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • 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
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Cardiology PC
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Caritas St. Elizabeth's Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • The Minneapolis Heart Institute at Abbott Northwestern Hospital

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

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be at least 21 years old
  • Have critical limb ischemia
  • Have severe blockages in at least one artery in the affected leg as demonstrated by an angiogram
  • Have nonhealing leg ulcers and/ or have severe rest pain secondary to a severely decreased blood flow
  • Agree to participate in follow-up.

Exclusion Criteria:

  • Have any evidence of malignant neoplasms (other than non-melanoma skin cancer or in situ carcinoma) within the last 5 years
  • Be pregnant or lactating
  • Have a history of alcohol or drug abuse within 3 months of screening
  • Have advanced (Rutherford Category 6) critical limb ischemia, characterized by extensive tissue loss or gangrene
  • Have osteomyelitis
  • Have undergone successful aortic or lower extremity surgery, angioplasty, or lumbar sympathectomy within the 2 months preceding screening
  • Be a suitable candidate for surgical or endovascular revascularization in the limb in which treatment is proposed
  • Subjects in whom arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder

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

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Collaborators and Investigators

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

Sponsor

Losordo, Douglas, M.D.

Investigators

  • Study Director: Douglas W. Losordo, MD, Northwestern University

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 Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

March 16, 2006

First Submitted That Met QC Criteria

March 16, 2006

First Posted (ESTIMATE)

March 20, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 19, 2010

Last Update Submitted That Met QC Criteria

October 18, 2010

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB-IND 11948

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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