Study of fibroblast growth factor (FGF-1) in patients who have critical limb ischemia with lesions in which revascularization is not an option.

The purpose of this study is to demonstrate the superiority of FGF-1 gene therapy treatment over placebo in the prevention of major amputation above the ankle of the treated leg or of death in critical limb ischemia (CLI) patients with skin lesions.  There will be approximately 490 patients recruited for this study.  At Rush University Medical Center we expect to recruit approximately 12 patients.  The treatment will be assigned randomly.

You may be eligible for this study if you:

• Are 50 years of age or greater

• Have critical limb ischemia with skin lesions (either ulcer(s) stable over the last 2-week interval or gangrene)

• Are unsuitable for standard revascularization of peripheral arterial disease

• Have a negative cancer screening for each body system

You are not eligible for this study if you:

• Have previous major amputation on the leg to be treated

• Are planned for major amputation within the first month following randomization

• Have infected gangrene involving the forefoot evidenced by imaging (X-RAY)

• Have had acute cardiovascular events (heart attack, stroke, coronary intervention) within last 3 months

• Have venous ulcers

This is a partial list of eligibility and exclusion criteria. To inquire whether you are eligible for this study, please call the contact number provided. If you choose to inquire via e-mail, please refer to the study title in your correspondence.