Severe Peripheral Artery Occlusive Disease Clinical Trial
Official title:
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Different Doses and Schedules of Administration of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs
due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can
be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an
extremity and often causes lifelong disablement from a painful leg. The clinical
consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue
integrity in the distal limbs.A variety of medical therapies have been investigated for
patients with PAOD. There is currently no evidence to suggest that any medical therapy is
effective for patients with rest pain and/or ischemic ulcers.
Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a
improvement in clinical and hemodynamic status in patients with severe PAOD
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