Background: Leg ulcers associated with chronic venous disease (CVD) are characterized by prolonged healing and high recurrence. This study describes the effectiveness and tolerability of venoactive drugs (VAD) combined with compression as part of conservative therapy for active venous leg ulcers among patients treated in routine clinical practice.
Methods: This prospective, multicenter, observational, 6-month study recruited patients diagnosed with Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) clinical class C6 and active venous ulcer area, 5-30 cm2. VAD pharmacotherapy was at the discretion of the treating physician and consistent with national guidelines at the time of the study. Primary outcome was the proportion of patients with a healed venous ulcer at 6 months. Change from baseline in the mean Venous Clinical Severity Score (VCSS), the proportion of patients with a reduction in CEAP clinical class, and Quality of life (QoL - Chronic Venous Insufficiency Questionnaire [CIVIQ-14]) were also assessed.
Results: The study enrolled 349 patients: 66.8% were women; mean age was 61.0±12.7 years; and mean Body Mass Index (BMI) was 27.9±4.1 kg/m2. Mean duration of the reference venous ulcer was 18.3±23.0 weeks and mean ulcer area was 9.2±6.9 cm2. All patients were prescribed VAD at baseline, most commonly micronized purified flavonoid fraction (MPFF) (98.3% patients). Compression therapy was prescribed to 91.1% of patients. After 6 months, venous ulcers had completely healed in 69.6% of patients; 13.5% had experienced complete healing at 3 months. Mean physician-assessed VCSS decreased from 15.5±4.1 at baseline to 9.7±4.5 at 6 months (P<0.001). There was a progressive decrease in mean reference ulcer area from 9.2±6.9 cm2 at baseline to 1.2±2.8 cm2 at 6 months. QoL was significantly improved with a reduction in mean CIVIQ-14 global index score from 53.9±20.5 at baseline to 24.5±16.3 at 6 months (P<0.001). Treatment was well tolerated.
Conclusions: Combined treatment with VAD and compression therapy was associated with complete venous leg ulcer healing in 70% of patients with a mean time to healing of 7.4 months. A significant improvement in QoL compared with baseline was also observed.