Sub-ulcer Ultrasound Guided Foam Sclerotherapy for Venous Leg Ulcers: Results of the FINNULCER Randomised Controlled Trial.

Abstract

The aim of this study was to evaluate the efficacy of adding sub-ulcer ultrasound guided foam sclerotherapy (UGFS) to the treatment of venous leg ulcers (VLUs). This was a multicentre, non-blinded, parallel group, randomised controlled trial. The FINNULCER trial recruited patients with VLU from four vascular surgery units in Finland. Eligible participants were randomly allocated either to the study group, which received immediate sub-ulcer UGFS in addition to conventional treatment, or to the control group, which received conventional treatment only. Conventional treatment included scheduled endothermal ablation for refluxing truncal veins, UGFS for tributaries, compression therapy, and local ulcer care. The recommended compression therapy was a class 2 (23 - 32 mmHg) thigh high compression stocking. The primary outcome was time to ulcer healing within 1 year of follow up. Secondary outcomes included quality of life questionnaires, treatment characteristics, and complications. Seventy-three patients were randomised (35 to the study group, 38 to the control group). During follow up, all ulcers healed in the study group, whereas four of 38 ulcers did not heal in the control group. The median time to ulcer healing was 55 days (95% confidence interval [CI] 42 - 68 days) in the study group and 91 days (95% CI 73 - 109 days) in the control group. In a Cox proportional hazards model adjusted for study site, ulcer healing was faster in the study group (hazard ratio 1.81, 95% CI 1.10 - 2.96; p = .019). Quality of life improved similarly in both groups. Overall complication rates were similar in both groups. Adding sub-ulcer UGFS to conventional VLU treatment shortened ulcer healing time without increasing the overall complication rate. These findings suggest that treatment of the sub-ulcer venous plexus may represent a useful addition to the management of VLUs, although the results should be interpreted in the context of a smaller study population than originally planned.