The Beneficial Augmentative Effect of Micronised Purified Flavonoid Fraction (MPFF) on the Healing of Leg Ulcers: An Open, Multicentre, Controlled, Randomised Study

Abstract

Objective: To determine the increase in healing rate of venous ulcer in patients receiving a micronised purified flavonoid fraction (MPFF) as supplementation to standard local care. Design: A randomised, open, controlled, multicentre study. Setting: Departments of Dermatology and University Outpatients Clinics. Patients: One hundred and forty patients with chronic venous insufficiency and venous ulcers. Intervention: Patients received standard compressive therapy plus external treatment alone or 2 tablets of MPFF daily in addition to the above treatment for 24 weeks. Main outcome measure: Healing of ulcers and their reduction in size after 24 weeks of treatment. Results: The percentage of patients whose ulcers healed completely was found to be markedly higher in those receiving MPFF in addition to standard external and compressive treatment than in those treated with conventional therapy alone (46.5% vs 27.5%; p<0.05, OR = 2.3, 95% CI 1.1–4.6). Ulcers with diameters <3 cm were cured in 71% of patients in the MPFF group and in 50% of patients in the control group, whereas ulcers between 3 and 6 cm in diameter were cured in 60% and 32% of patients ( p<0.05), respectively. The mean reduction in ulcer size was also found to be greater in patients treated with MPFF (80%) than in the control group (65%) ( p<0.05). The cost-effectiveness ratio (cost per healed ulcer) in the MPFF group was €1026.2 compared with €1871.8 in the control group. Conclusions: These results indicate that MPFF significantly improves the cure rate in patients with chronic venous insufficiency.

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.…”

Essentials of Daflon 500 mg: From Early Valve Protection to Long-Term Benefits in the Management of Chronic Venous Disease

“…In the Glinski et al study, ulcers with a diameter less than 3 cm were cured in 71% of the Daflon 500 mg group and 50% of the standard therapy group [84]. When the ulcer's diameter was between 3 6 cm, they were cured in 60% and 32% (P<0.05) in the Daflon 500 mg and control group, respectively.…”

“…The efficacy of Daflon 500 mg in augmenting the healing of venous ulcers has been evaluated in three, randomized, controlled, multicenter trials in which two tablets of Daflon 500 mg daily plus standard venous leg ulcer management were compared with standard venous leg ulcer management (compression therapy plus local treatment) alone [84,85] or in addition to placebo [86]. In all three studies, there was a significantly higher ulcer healing rate in patients treated with Daflon 500 mg compared with the control group ( Table 4).…”

“…The mean reduction in ulcer size was found to be greater in patients treated with Daflon 500 mg than in the control patients: 80% versus 60%, P<0.05 in the Glinski et al trial [84] and 77% versus 69%, P=0.012 in the Roztocil et al trial [85].…”

Chronic venous insufficiency: the effects of health-care reforms on the cost of treatment and hospitalisation -an Italian perspective

“…Indeed, in association with conventional treatment (i.e. compression therapy and local treatment), flavonoids have been shown to be able to reduce venous leg ulcer healing time more effectively than conventional treatment on its own [16][17][18][19][20] . Thus, pharmacological treatment is widely used at all stages of CVI both in monotherapy (in the early stages), or in combined therapy for venous leg ulcers.…”