Treatment of limb threatening ischaemia with intravenous iloprost: a randomised double-blind placebo controlled study. U.K. Severe Limb Ischaemia Study Group.

A number of patients (151) with ischaemia of the lower limb presenting as ulcers or gangrene and/or rest pain were entered into a multicentre randomised double-blind controlled study of intravenous iloprost or placebo given for 14-28 days. Patients were assessed for evidence of ulcer healing as judged by reduction in size with granulation at the base and relief of rest pain sufficient for discharge from hospital. Based on these criteria, 45% in the iloprost and 29% in the placebo group showed evidence of improvement of clinical status at the end of treatment (p less than 0.05). At 6 months follow-up improvement was maintained in 42% of iloprost patients and 26% of placebo patients (p less than 0.01). At this follow up 64% of the iloprost patients and 42% of the placebo patients were alive with a viable limb. Thirty-one per cent of the iloprost patients and 47% of the placebo patients underwent major amputation (p less than 0.05). It has been shown that iloprost significantly improves patients with ischaemic ulcers or gangrene compared with placebo. This improvement is maintained for up to 6 months after treatment resulting in a reduced major amputation rate.