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).
|Critical Limb Ischemia Ischemia Leg Ulcer||Genetic: pVGI.1 (VEGF-2)||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304837
|United States, Alabama|
|Birmingham, Alabama, United States, 35211|
|United States, Massachusetts|
|Caritas St. Elizabeth's Medical Center|
|Boston, Massachusetts, United States, 02135|
|United States, Minnesota|
|The Minneapolis Heart Institute at Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|Study Director:||Douglas W. Losordo, MD||Northwestern University|