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Sponsored by Chiron Corporation, Emeryville, CA. IntroductionIntermittent claudication (muscular pain of the legs during walking that is relieved at rest) is a symptom of obstructive atherosclerosis. When the blockage is at the level of the aorta or iliac arteries (in the pelvis), both surgery and catheter-based treatments are good treatments. They provide durable relief of claudication symptoms, generally with low risk to the patient. However, blockages below the level of the groin often are not as easily treated. Both surgery and catheter-based treatment have significant shortcomings, including a high-likelihood that the blockage will return, or that bypass grafts will clot or fail, or that veins will be unavailable for later, more-critical surgical procedures. For this reason, mechanical treatments are usually reserved for patients with limb-threatening ischemia. Other treatments are offered to patients claudication from artery blockage below the level of the groin. They include intensive exercise training, risk-factor modification (treatment of smoking, cholesterol-reduction, blood pressure and diabetes control). Drug treatments are often ineffective (like pentoxifylline) or potentially hazardous (like cilostazol) or difficult to tolerate (prostacyclins). Newer drug treatments may prove useful in the future (propionyl-L-carnitine). Therapeutic angiogenesis using protein or gene growth factors are promising new modalities. Fibroblast growth factor-2 (FGF-2) is one of a large class of angiogenic growth factor proteins that promote the growth of collateral blood vessels. In animal models, rFGF-2 improves blood flow to the legs. Early human studies also show evidence of improved blood flow to the legs of patients with claudication after rFGF-2 treatment. This clinical trial is a Phase II multicenter, double-blind, placebo-controlled study of recombinant fibroblast growth factor (rFGF-2) protein in 180 subjects with intermittent claudication because of atherosclerotic blockages in the arteries below the level of the groin. Patients will be randomized to receive placebo or one or two doses of rFGF-2, administered via catheter directly into the arteries supplying their legs. Major Trial Activity
Major inclusion criteria
Major Exclusion Criteria
Primary Endpoint
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