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(R) 500 mg (Dies) in venous ulcers. A multicenter, double-blind, randomiz ed, controlled versus placebo (Plac) trial was conducted, with stratif ication according to the size of ulcer (less than or equal to 10 cm an d > 10 cm). The protocol called for a two-month treatment with Dies (o ne tablet = 450 mg micronized purified Diosmin) or a placebo, two tabl ets/day, in addition to compression therapy. Evaluations were performe d every fifteen days, from D0 to D60. The primary endpoint, in accorda nce with Alexander House group requirements were: percentage of patien ts with complete ulcer healing, ie, comparison between Dies and Plac g roup at D60, and comparison of survival curves in each group between D 0 and D60 (log rank test). Secondary endpoints included ulcer surface area assessed by computerized planimetric measurements, qualitative ev aluation of ulcers, and symptoms. The patients were 105 men and women ranging in age from eighteen to eighty-five years, with standard compr ession stocking, who were undergoing standardized local care of ulcer and had no significant arterial disease (ankle/arm systolic pressure i ndex > 0.8). Fifty-three patients received Dies, and 52 received Plac. The 2 groups were well matched for age (m +/- 1 SD = seventy-one +/- eleven years), gender, ulcer size, and associated disorders. Among pat ients with ulcer size less than or equal to 10 cm (Dios = 44, Plac = 4 7) a significantly larger number of patients had a complete ulcer heal ing at two months in the Dies group (n = 14) in comparison with the Pl ac group (n = 6) (32% vs 13%, P = 0.028) with a significantly shorter time duration of healing (P = 0.037). No difference was shown for the secondary criteria, except for sensation of heavy legs (P = 0.039) and a less atonic aspect of ulcer (P = 0.030) in favor of Dios. Among the 14 patients with ulcer size > 10 cm (Dios = 9, Plac = 5), subjected t o a descriptive analysis only, no ulcer healed. This study showed that a two-month course of Daflon 500 mg at a daily dose of two tablets, i n addition to conventional treatment, is of benefit in patients with v enous ulcer less than or equal to 10 cm by accelerating complete heali ng.