VEGF Gene Transfer for Critical Limb Ischemia

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).

Completed

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cardiology PC, Birmingham, Alabama, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pVGI.1 (VEGF-2)

Genetic

Sponsors and collaborators

Lead sponsor

Losordo, Douglas, M.D.

Indiv

Registry information

Important dates

Study completion: 2008
First posted: Mar 20, 2006
Registry last updated: Oct 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed