Finnish Venous Ulcer Study (FINNULCER Study)

Sponsor
Oulu University Hospital
Study ID
NCT04737941
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endothermal Ablation — PROCEDURE
    Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)
  • Foam Sclerotherapy — PROCEDURE
    Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.

Study Details

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

Key Dates

First listed
Feb 4, 2021
Start date
Feb 26, 2021
Status verified
Jan 2025
Primary completion
Mar 1, 2025
Completion
Mar 1, 2026

Study Design

Enrollment
248 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: First-visit foam sclerotherapy
    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.
  • Active Comparator: Scheduled treatment
    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.

Primary Outcome Measure

Time to ulcer Healing [ Time Frame: 0-365 days ]

Central Contacts

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