Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions. Secondary objectives are to evaluate: * The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation; * The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death; * The safety of riferminogene pecaplasmid in the study population.
The study consists in 6-week treatment then a follow-up period up to 12 months. A follow-up contact is then scheduled 6 months later. Per protocol amendment a 18-month long-term safety survey was added.
Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated
Formulation: 5 ml glass vials containing 2,5 ml placebo Route: IM injection of 2.5 mL in the ischemic leg to be treated
Buenos Aires, Argentina