Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease
Status:
Completed
Trial end date:
2005-04-01
Target enrollment:
Participant gender:
Summary
This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR
plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients
with severe Peripheral Arterial Occlusive Disease, Fontaine's stage IV. The efficacy was
assessed by the complete healing of at least one ulcer in the treated limb, 25 week
post-baseline and secondary by the rate of amputation and death.