Finnish Venous Ulcer Study (FINNULCER Study)

Not Applicable

Recruiting

• Conditions: Venous Leg Ulcer

• Registration Number: NCT04737941
• Lead Sponsor: Oulu University Hospital

Brief Summary

This multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer.

Detailed Description

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

In addition to the first-visit treatment in the study group, both groups receive endothermal ablation and/or foam sclerotherapy to (further) treat ulcer-related insufficient veins and truncal insufficiency in scheduled treatment visit(s).

Class 2 thigh-high compression or the best possible compression therapy tolerated by the patient is provided in both groups. The follow-up period for the primary outcome is one year.

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).

Study Timeline

• Study First Submitted: 2021-01-30
• Study First Submitted QC: 2021-01-30
• Study First Posted: 2021-02-04
• Study Start: 2021-02-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

• Patient informed consent
• Venous ulcer, aged from one month to one year
• Duplex ultrasonography verified (vein reflux greater than >0.5 second) superficial venous insufficiency
• Sufficient arterial circulation (at least on criterion met: Palpable distal pulses / ankle-brachial index > 0,8 / Toe pressure >60mmhg)

Exclusion Criteria

• Leg ulcers other than venous etiology
• Ulcers requiring operation theater revision
• Patent foramen ovale
• Several times recurrent (over 3 recurrences) venous ulcer
• Body Mass Index over 40
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to ulcer Healing	0-365 days	Complete re-epithelialisation of ulcer area

Secondary Outcome Measures

Name	Time	Method
EQ-5D Questionnaire	0-365 days	Score 0-100 where higher is better
Venous ulcer area	0-365 days	Reduction on venous ulcer maximum diameter
Wound-QOL Questionnaire	0-365 days	Score 0-17 where lower is better

Trial Locations

Locations (5)

Keski-Suomen keskussairaala; 🇫🇮 Jyväskylä, Finland

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Vaasa Central Hospital; 🇫🇮 Vaasa, Finland