Finnish Venous Ulcer Study (FINNULCER Study)

Venous Ulcer Clinical Trial

Official title: Finnish Venous Ulcer Study

Status Recruiting

Clinical Trial Summary

This multicenter randomized controlled trial compares immediate foam sclerotherapy vs. scheduled endovenous treatment in patients with venous ulceration.

Clinical Trial Description

To evaluate the effect of first-visit foam sclerotherapy, patients with venous ulcer are randomly assigned to first-visit foam sclerotherapy- or to scheduled treatment group. The primary outcome for this study is time to ulcer healing.

For this study, based on Oulu University Hospital's retrospective data (partly published in Pihlaja et al 2020) of venous ulcer healing the investigators assumed Hazard Ratio 1.5 for venous ulcer to heal in first-visit foam sclerotherapy group compared to scheduled treatment group.

Assuming drop-out of 10% this study recruits total of 248 patients (a=0.05, b=0.2).

For the primary outcome the follow-up time is one year. In both groups endothermal ablation and/or foam sclerotherapy are used to treat the ulcer-related insufficient veins and truncal insufficiency. Class 2 thigh-high compression, or best possible compression therapy patient tolerates is facilitated in both groups ;

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcer

• NCT number: NCT04737941
• Study type: Interventional
• Source: Oulu University Hospital
• Contact: Matti Pokela, Docent
• Phone: 083152011
• Email: matti.pokela@ppshp.fi
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2021
• Completion date: March 1, 2026