Efficacy of Daflon 500 mg in venous leg ulcer healing: a double-blind, randomized, controlled versus placebo trial in 107 patients.

The objective of this study was to evaluate the efficacy of Daflon 500 mg (Dios)* in venous ulcers. A multicenter, double-blind, randomized, controlled versus placebo (Plac) trial was conducted, with stratification according to the size of ulcer (< or = 10 cm and > 10 cm). The protocol called for a two-month treatment with Dios (one tablet = 450 mg micronized purified Diosmin) or a placebo, two tablets/day, in addition to compression therapy.

A long term treatment with a venotropic drug. Results on efficacy and safety of Daflon 500 mg in chronic venous insufficiency.

Unlabelled: Drugs for long term administration have to prove their efficacy and safety. Previously published double blind controlled studies (from single dose to two months treatment) have already demonstrated the phlebotropic activity of Daflon 500 mg in chronic venous insufficiency (CVI). The aim of the study was to investigate the safety of this agent during one year of continuous administration.