[Assessment by transcutaneous PO2 measurement of the treatment of venous ulcers with naftidrofuryl].

A double-blind therapeutic trial was undertaken in 40 subjects with large venous ulcers and distributed on a homogeneous basis. They were treated with naftidrofuryl by intravenous infusions for one week followed by oral treatment for three months, in comparison with a placebo (infusions of saline and lactose tablets). All the patients received the same local treatment. Results were assessed not only clinically (changes in ulcer) but also objectively by the measurement of TcPO2. TcPO2 by the measurement of transcutaneous tissue oxygenation is an indicator of the state of the microcirculation and hence the trophic condition of the tissues. Study of the results (Student t) showed that in the treated group and at the ulcer site there was a significant (p less than 0.05) difference from D7 onwards, which increased further during treatment (p less than 0.02 at 3 months). For the placebo group, significance occurred only at D90 (p less than 0.05). The intergroup course difference was itself significant at D45 and D90. The tolerance of naftidrofuryl in both of its forms was unremarkable. Clinical study showed a good correlation between improvement in PO2 and ulcer healing. This trial confirmed the efficacy of naftidrofuryl in the treatment of venous ulcers.

RCT Entities:   Population Interventions Outcomes