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document
A stable prostacyclin analogue ( iloprost ) in the treatment of ischaemic ulcers of the lower limb . A Scandinavian-Polish placebo controlled , randomised multicenter study . The clinical efficacy of the prostacyclin analogue iloprost was studied during a 2 week treatment and 6 month follow-up period in 103 patients with ischaemic ulcers who were randomised to receive active treatment or placebo . Responders were defined as those patients who achieved healing of at least one third of the ulcer area during the study period . The overall responder rate was 41.3 % , compared with 25 % for the control group ( P = 0.086 ) . Side effects including flushing and headache , were common . The study population had a mortality of 23 % during the 6 month period , the amputation rate was 43.5 % for iloprost and 50 % for placebo treated patients . In this severely diseased population of patients a treatment period limited to 2 weeks did not sufficiently improve ulcer healing .
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Intervention_Pharmacological
stable prostacyclin analogue ( iloprost )
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Intervention_Control
placebo
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Intervention_Pharmacological
prostacyclin analogue iloprost
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Intervention_Pharmacological
active treatment
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Intervention_Control
placebo
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Intervention_Pharmacological
iloprost
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Intervention_Control
placebo
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Outcome_Other
clinical efficacy
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Outcome_Physical
responder rate
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Outcome_Adverse-effects
flushing and headache
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Outcome_Mortality
mortality
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Outcome_Physical
amputation rate
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Outcome_Physical
ulcer healing
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Participant_Condition
ischaemic ulcers
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Participant_Sample-size
103