The beneficial augmentative effect of micronised purified flavonoid fraction (MPFF) on the healing of leg ulcers: An open, multicentre, controlled, randomised study

Objective: To determine the increase in healing rare of venous ulcer in pat ients receiving a micronised purified flavonoid fraction (MPFF) as suppleme ntation 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 treatme nt for 24 weeks. Main outcome measure: Healing of ulcers and their reduction in size after 2 4 weeks of treatment. Results: The percentage of patients whose ulcers healed completely was foun d to be markedly higher in those receiving MPFF in addition to standard ext ernal and compressive treatment than in those treated with conventional the rapy 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 diam eter 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 w ith MPFF (80%) than in the control group (65%) (p<0.05). The cost-effective ness ratio (cost per healed ulcer) in the MPFF group was euro 1026.2 compar ed with euro 1871.8 in the control group. Conclusions: These results indicate that MPFF significantly improves the cu re rate in patients with chronic venous insufficiency.