VIEW-VLU Observational Study of the Effect of Varithena on Wound Healing in the Treatment of Venous Leg Ulcers.

OBJECTIVES: Chronic venous hypertension, triggered by venous reflux and/or obstruction, leads to skin changes and venous leg ulcers. Compression therapy is standard of care, but many wounds remain unhealed. The objectives of this study were to observe the effects of endovenous chemical ablation with commercially available 1% polidocanol injectable microfoam on venous leg ulcer healing and recurrence rates.

METHODS: The VIEW VLU study was a multicenter, open-label, Phase 4 registry of patients with active venous leg ulcers resulting from venous insufficiency of the great saphenous vein and/or anterior accessory saphenous vein systems who underwent ablation with 1% polidocanol microfoam. Primary outcomes included wound healing rate (change in wound perimeter), wound closure at 12 weeks post-treatment, and time to wound closure. Secondary outcomes included venous leg ulcer recurrence, numeric pain score at the ulcer location, EuroQol five-dimension five-level questionnaire quality-of-life index, and the Venous Clinical Severity Score. Patients were followed for 12 months.

RESULTS: 76 patients (80 ulcers) from 14 sites across the USA and Canada were enrolled (mean age 63.6±13.7 years, 39.5% female sex, mean body mass index 36.3). 96.3% presented with great saphenous vein incompetence. Mean baseline wound perimeter was 117.2±107.4 mm and 26.3% (21/80) of wounds were circumferential. Mean ulcer age was 34.8 ± 51.8 weeks at first presentation and mean compression therapy duration was 26.4±35.9 weeks. Median wound perimeter decreased 16.3% from baseline in the first two weeks post-procedure, and 27% at 12 weeks. By 12 weeks, 53.8% (43/80) of wounds were healed. Median time to ulcer closure by Kaplan Meier analysis was 89 days (95%CI 62.0, 117.0). In Kaplan-Meier analysis of initially healed wounds, 88.9% (95%CI; 76.9, 94.8) remained closed 12 weeks post-closure. Mean numeric pain scores (ulcer site) improved by 41.0% and 64.1% at 12 weeks and 12 months post-procedure, respectively. The health-related quality-of-life index (scale of 0-1) improved from 0.65±0.27 at baseline to 0.72±0.28 at 12 weeks and 0.73±0.30 at 12 months. By 12 weeks post-treatment, the mean target leg Venous Clinical Severity Score had significantly decreased by 5.8 points, and by 12 months had decreased by 10.0 points.

CONCLUSIONS: Treatment with 1% polidocanol microfoam was associated with promising wound healing rates and low recurrence rates for venous leg ulcers, despite a challenging patient population with recalcitrant ulcers, a large percentage of which were circumferential, in patients with high body mass indexes.