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Recombinant fibroblast growth factor-2 (rFGF-2) improves perfusion in models of myocardial and hindlimb ischaemia. We investigated whether one or two doses of intraarterial rFGF-2 improves exercise capacity in patients with moderate-to-severe intermittent claudication.

190 patients with intermittent claudication caused by infra-inguinal atherosclerosis were randomly assigned (1:1:1) bilateral intra-arterial infusions of placebo on days 1 and 30 (n=63); rFGF-2 (30 μg/kg) on day 1 and placebo on day 30 (single-dose, n=66); or rFGF-2 (30 μg/kg) on days 1 and 30 (double-dose, n=61). Primary outcome was 90-day change in peak walking time. Secondary outcomes included anklebrachial pressure index and safety. The main analysis was per protocol.

Before 90 days, six patients had undergone peripheral revascularisation and were excluded, and ten withdrew or had missing data. 174 …