Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
Participant gender:
Summary
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