Benefit of a 2-Month Treatment with a Micronized, Purified Flavonoidic Fraction on Venous Ulcer Healing

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 < 10 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 ≤10cm (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 ≤ 10 cm in diameter.

Management of venous leg ulcers: Clinical practice guidelines of the Society for Vascular Surgery® and the American Venous Forum

“…The discovery of the involvement of leukocytes in the pathophysiologic mechanism of VLUs has opened another pathway for successful investigations. 467 Two systemic drugs interacting with leukocyte activation have demonstrated an effect on VLU healing, micronized purified flavonoid fraction (MPFF or Daflon) 14,[468][469][470][471][472][473][474][475][476] and pentoxifylline. 286,474,[477][478][479][480][481][482][483] MPFF protects the microcirculation from the damage induced by venous ambulatory hypertension.…”

Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial

“…5 Although compression is still the undisputed standard of ulcer management, 6 drug therapy may be considered where there is intolerance, contraindications, lack of compliance or as an adjunct to accelerate the healing process. 7 Statins are cholesterol-lowering drugs that may have pleiotropic effects that accelerate wound healing. [8][9][10] As most available data are based on animal studies, 11 there have been no studies investigating the use of statins in the treatment of venous ulcers.…”

“…Venous ulceration reduces quality of life and imposes financial constraints . Although compression is still the undisputed standard of ulcer management, drug therapy may be considered where there is intolerance, contraindications, lack of compliance or as an adjunct to accelerate the healing process …”

New Synthetic Diosmetin Derivatives: Effects on Different Experimental Models of the Microcirculation

“…Thus these substances can scavenge free radicals [5], prevent lipid peroxidation [7], and inhibit low-density lipoprotein oxidation [4, 10]; they also possess anti-inflammatory actions [1] and inhibit enzymes such as cyclooxygenases, lipoxygenases, and phospholipase A 2 [6]. Also actions, related or not to the antioxidant properties, such as prevention of thrombosis [11], prevention of platelet activation [12], inhibition of plasminogen activator inhibitor-1 (PAI-1) production [13] or stimulation of endothelium-dependent relaxation [14] have been reported.A purified micronized flavonoid fraction (Daflon 500 mg) 1 was recently shown to have a beneficial effect on venous ulcer healing [15]. This flavonoid fraction, which consists of 90% diosmin and 10% hesperidin, is clinically used for the treatment of chronic venous insufficiency and hemorrhoidal attacks; its anti-edematous properties in man have previously been demonstrated [16].…”

“…A purified micronized flavonoid fraction (Daflon 500 mg) 1 was recently shown to have a beneficial effect on venous ulcer healing [15]. This flavonoid fraction, which consists of 90% diosmin and 10% hesperidin, is clinically used for the treatment of chronic venous insufficiency and hemorrhoidal attacks; its anti-edematous properties in man have previously been demonstrated [16].…”