Benefit of a 2-month treatment with a micronized, purified flavonoidic fraction on venous ulcer healing. A randomized, double-blind, controlled versus placebo trial.

Abstract

OBJECTIVE:

To assess the efficacy of a micronized purified flavonoid fraction (Daflon 500 mg = Dios) in venous leg ulcer healing, in addition to compression therapy and standardized local care.

DESIGN:

Double-blind, multicentre, randomized, parallel groups, controlled versus placebo trial; stratification according to ulcer size.

SUBJECTS:

107 patients, with venous ulcer of the leg for at least 3 months, and accepting bandaging therapy.

RESULTS:

105 patients (Dios = 53, placebo = 52) were 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 (Dios = 51, placebo = 48). Among the 91 patients with ulcer size < or = 100 cm (Dios = 44, placebo = 47), a significantly higher number of patients had complete ulcer healing at 2 months in the Dios group (n = 14) in comparison to the placebo group (n = 6) after ITT analysis (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 (Dios = 9, placebo = 5), no ulcer healed.

CONCLUSION:

This study showed that a 2-month course of purified micronized flavonoid fraction (2 tablets/day), in addition to conventional treatment, is of benefit in patients by accelerating complete healing of venous leg ulcers which are < or = 10 cm in diameter.

• Authors: J J Guilhou, F Février, C Debure, D Dubeaux, M N Gillet-Terver, B Guillot, H Levesque, L Marzin, J Mignot, P Ouvry, G Pillion, H Van Landuyt, F Zuccarelli, A N Nicolaïdes
• Journal: International journal of microcirculation, clinical and experimental (Int J Microcirc Clin Exp) Vol. 17 Suppl 1 Pg. 21-6 ( 1997) ISSN: 0167-6865 [Print] Switzerland
• PMID: 9477041 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Drug Combinations
• Diosmin
• Hesperidin

Topics

• Adolescent
• Adult
• Aged
• Diosmin (therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Combinations
• Female
• Hesperidin (therapeutic use)
• Humans
• Leg Ulcer (drug therapy)
• Male
• Middle Aged
• Time Factors
• Treatment Outcome
• Venous Insufficiency (drug therapy)
• Wound Healing (drug effects)