Trial protocol for evaluating sub-ulcer foam sclerotherapy as an adjunct to conventional endovenous treatment in patients with venous leg ulcers: The FINNULCER multicenter randomized controlled trial

Abstract

Background

Venous leg ulcers (VLUs) affect approximately 1% of the adult population and incur significant morbidity and healthcare costs. Endovenous interventions, such as endovenous laser ablation (EVLA) and ultrasound-guided foam sclerotherapy (UGFS), have shown benefits in treating venous insufficiency in patients with VLUs. However, the effect of specifically targeting the sub-ulcer venous plexus with foam sclerotherapy remains poorly understood.

Objective

The FINNULCER trial is investigating the addition of sub-ulcer foam sclerotherapy to conventional endovenous treatment (EVLA + UGFS) for managing superficial venous insufficiency in patients with VLUs. The primary aim is to evaluate the effect of sub-ulcer foam sclerotherapy in promoting ulcer healing.

Methods

Patients with VLUs are being screened at four vascular surgery units in Finland. Eligible participants who provide informed consent are randomized into the study group to receive sub-ulcer foam sclerotherapy + EVLA + UGFS or into the control group to receive EVLA + UGFS. The primary outcome is the time to ulcer healing during 1 year of follow-up from randomization. Secondary outcomes include quality of life assessments and procedure-related outcomes.

Trial registration

ClinicalTrials.gov (NCT04737941).