BENEFIT OF A 2-MONTH TREATMENT WITH A MICRONIZED, PURIFIED FLAVONOIDIC FRACTION ON VENOUS ULCER HEALING - A RANDOMIZED, DOUBLE-BLIND, CONTROLLED VERSUS PLACEBO TRIAL

Objective: To assess the efficacy of a micronized purified flavonoid f raction (Daflon 500 mg = Dies) in venous leg ulcer healing, in additio n to compression therapy and standardized local care. Design: Double-b lind, multicentre, randomized, parallel groups, controlled versus plac ebo trial; stratification according to ulcer size. Subjects: 107 patie nts, with venous ulcer of the leg for at least 3 months, and accepting bandaging therapy. Results: 105 patients (Dies = 53, placebo = 52) we re available for an intention to treat (ITT) analysis. Age(mean +/- SD , 71 +/- 11 years), gender (M = 33, F = 74) and ulcer size were evenly distributed among both groups. 99 patients completed the protocol (Di es = 51, placebo = 48). Among the 91 patients with ulcer size less tha n or equal to 10 cm (Dies = 44, placebo = 47), a significantly higher number of patients had complete ulcer healing at 2 months in the Dies group (n = 14) in comparison to the placebo group (n = 6) after ITT an alysis (32 vs. 13%, p = 0.028) and after per protocol analysis (32 vs. 14%, p = 0.048), and a shorter time duration of healing (p = 0.037). Among the 14 patients with ulcer size >10 cm (Dies = 9, placebo = 5), no ulcer healed. Conclusion: This study showed that a 2-month course o f purified micronized flavonoid fraction (2 tablets/day), in addition to conventional treatment, is of benefit in patients by accelerating c omplete healing of venous leg ulcers which are less than or equal to 1 0 cm in diameter.