Evaluation of ifenprodil efficacy on exercise-induced tissue ischemia in stage II arteriopathy by measurement of transcutaneous oxygen tension during a standard treadmill test: double-blind study of injectable ifenprodil versus placebo.

Measurement of transcutaneous oxygen tension (TcPO2) is a noninvasive and easily reproducible method for objectifying and quantifying exercise ischemia in patients with stage II occlusive arterial disease. This technique is also used at rest to evaluate the therapeutic effect of vasoactive treatments. To objectively assess the effectiveness of a vasoactive treatment on the conditions of tissue perfusion, a randomized double-blind study of ifenprodil tartrate versus placebo was performed in 20 patients, whose TcPO2 was continuously measured while they walked on a treadmill. Patients treated with ifenprodil improved significantly as compared with the placebo group, for both the half-hypoxia area, representing the overall evolution of the tissue ischemia (+34.9% and -16.0%, respectively, p = 0.01), and the half-hypoxia recovery time, estimating the postexercise recovery time (+30.2% and -3.6%, respectively, p < 0.05). This study confirms that the continuous measurement of TcPO2 during the recovery phase after exercise represents an objective method for the evaluation and follow-up of patients with stage II intermittent claudication. The results enabled the objective assessment of ifenprodil efficacy on the evolution of tissue hypoxia.