“…16 TALISMAN PM 201 (n¼118) was a phase II, double-blind, placebo-controlled, multicenter, safety and efficacy trials comparing intramuscular injections of four times 4 mg of NV1FGF versus placebo in patients with CLI and at least one non-healing ulcer and no option for revascularization in Europe. 11,14 TALISMAN PM 201 demonstrated a significant reduction in all amputations and 55% risk reduction of major amputations as well as a delay in time to major amputation or death in CLI patients. 14 There was no difference in ulcer healing, probably because of the severity of the baseline lesions.…”