[Effectiveness of a micronized purified flavonoid fraction (MPFF) in the healing process of lower limb ulcers. An open multicentre study, controlled and randomized].

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.