[Drug evaluation methods in lower limb arteriopathy]

The prevalence and severity of chronic vascular leg disease explains the necessity to clarify methods for assessing it. Today the methods are both clinical and paraclinical. Clinically, they are based on the Fontaine and Leriche classification and appearance of ischaemic pain. Paraclinically, they are measuring distal blood pressure, artery output, micro-circulation, rheology, and tissular metabolism. But this approach must be also global, assessing coronary and carotid disease. Trials methodology includes a first step of explanatory studies by paraclinical ways and lastly pragmatic efficacy and tolerability studies. We recommend an accurate selection of patients and a stratification. The disease must be stable and the treatment and diet too. The trials should be randomised vs placebo. In conclusion we propose a multiparametric classification of the disease.