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Recruiting NCT04737941

Finnish Venous Ulcer Study (FINNULCER Study)

No phase Interventional Venous Leg Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endothermal Ablation, Foam Sclerotherapy.
Who it may be relevant to
Registry conditions: Venous Leg Ulcer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Finnish Venous Ulcer Study

Overview

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).

Interventions

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

Primary outcome measures

  • Time to ulcer Healing [Time frame: 0-365 days]
Secondary outcome measures (3)
  • EQ-5D Questionnaire [Time frame: 0-365 days]
  • Wound-QOL Questionnaire [Time frame: 0-365 days]
  • Venous ulcer area [Time frame: 0-365 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 5 centers
  • Helsinki University Central Hospital — Helsinki
  • Keski-Suomen keskussairaala — Jyväskylä
  • Oulu University Hospital — Oulu
  • Turku University Hospital — Turku
  • Vaasa Central Hospital — Vaasa

Publications

  • Pihlaja T, Torro P, Ohtonen P, Romsi P, Pokela M. Ten years of experience with first-visit foam sclerotherapy to initiate venous ulcer healing. J Vasc Surg Venous Lymphat Disord. 2021 Jul;9(4):954-960. doi: 10.1016/j.jvsv.2020.11.012. Epub 2020 Nov 25. PMID 33248300
  • Pihlaja T, Ohtonen P, Hakovirta H, Viljamaa J, Kukkonen T, Venermo M, Halmesmaki K, Pokela M. 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. Phlebology. 2025 Oct;40(9):713-718. doi: 10.1177/02683555251335618. Epub 2025 Apr 17. PMID 40243046

Identifiers

NCT: NCT04737941 · 3/2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗