Finnish Venous Ulcer Study (FINNULCER Study)

Oulu University Hospital

Status: Enrolling

Conditions: Venous Leg Ulcer

Treatments: Procedure: Foam Sclerotherapy; Procedure: Endothermal Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04737941

3/2021

Details and patient eligibility

About

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

Full 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).

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

First-visit foam sclerotherapy

Experimental group

Description:

Patients in the first-visit foam sclerotherapy group undergo first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy), and truncal vein endothermal ablation is scheduled when the anatomy is suitable. Compression therapy is initiated immediately.

Treatment:

Procedure: Endothermal Ablation

Procedure: Foam Sclerotherapy

Scheduled treatment

Active Comparator group

Description:

Patients in the scheduled treatment group receive scheduled endovenous ablation, including foam sclerotherapy and/or endothermal ablation, depending on reflux anatomy. This group represents the current standard of care. Compression therapy is initiated immediately.

Treatment:

Procedure: Endothermal Ablation

Procedure: Foam Sclerotherapy