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XRP0038 · TALISMAN202

Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.

Ensayo de Sanofi en Severe Peripheral Artery Occlusive Disease (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

71

previstos

Centros

1

Fin del objetivo primario

jul 2005

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en jun 2002.

Qué mide

evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD. (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPeripheral 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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Ficha completa en ClinicalTrials.gov (NCT00798005), actualizada en jun 2017.