It identifies also a group of vascular surgeons and angiologists, who in the last few years have been undertaking a permanent research program in this area, which is still 'orphan', with respect to the availability of reliable epidemiological data and standardized clinical procedures. Stimulated by the suggestions of an European consensus, the i.c.a.i. group addresses several unsettled issues of CLI: it drew a profile of the different diagnostic and therapeutic interventions used in CLI, in order to assess the consistency of the current procedures with the recommendations of the consensus as well as their practicability. This epidemiological survey served also as a feasibility phase of subsequent intervention studies: it provided information on the prognostic profile of a real population observed in routine conditions of care, thus allowing a careful estimation of the population to be recruited in clinical trials conducted in the same setting. A large scale randomised trial was actually performed, addressing a long unanswered question, it provided evidence of some benefits of the use of prostanoids in CLI. Though small and short-lasting, the advantage is of apparent clinical relevance for a severe clinical condition for which effective treatments were so far unavailable. On its turn, the trial data base (including over 1,500 patients) offers now an epidemiological background suitable to identify the outcome predictive factors in the natural history of CLI, generate further hypothesis related to particular risk subgroups and revise the adequacy of the consensus recommendations.
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