VEGF Gene Transfer for Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304837
• Other study ID #: BB-IND 11948
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2006
• Last updated: October 18, 2010
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: Losordo, Douglas, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2008
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia
• Leg Ulcer

Intervention

Genetic:
• pVGI.1 (VEGF-2)

Locations

Country	Name	City	State
United States	Cardiology PC	Birmingham	Alabama
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	The Minneapolis Heart Institute at Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Losordo, Douglas, M.D.

Country where clinical trial is conducted

United States,