Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04737941

Finnish Venous Ulcer Study Randomized Trial of First-Visit Foam Sclerotherapy Versus Scheduled Treatment for Venous Leg Ulcers

Led by Oulu University Hospital · Updated on 2025-01-15

248

Participants Needed

5

Research Sites

261 weeks

Total Duration

On this page

Sponsors

O

Oulu University Hospital

Lead Sponsor

H

Helsinki University Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to assess the impact of first-visit foam sclerotherapy on patients with venous leg ulcers. It compares this approach to the current standard scheduled treatment to determine which leads to faster ulcer healing. The study is based on prior data suggesting potential benefits of early foam sclerotherapy and includes patients with ulcers lasting between one month and one year. Participants are randomly assigned to either receive foam sclerotherapy at their first visit or to follow the scheduled treatment plan. Both groups also receive endothermal ablation and/or foam sclerotherapy during scheduled visits to treat problematic veins related to the ulcer. All participants use class 2 thigh-high compression stockings or the best tolerated compression therapy as part of their care. The treatments focus on insufficient truncal and distal veins. During the study, patients are monitored for up to one year to measure the time it takes for their ulcers to heal. Researchers use duplex ultrasonography to verify vein reflux and assess arterial circulation. Safety and healing progress are carefully tracked, with the primary outcome being the duration until ulcer healing. The total study plans to enroll 248 patients to ensure reliable results.

CONDITIONS

Official Title

Finnish Venous Ulcer Study (FINNULCER Study)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient informed consent
  • Venous ulcer lasting from one month to one year
  • Duplex ultrasonography verified superficial venous insufficiency with vein reflux greater than 0.5 second
  • Sufficient arterial circulation demonstrated by at least one: palpable distal pulses, ankle-brachial index > 0.8, or toe pressure > 60 mmHg
Not Eligible

You will not qualify if you...

  • Leg ulcers caused by reasons other than venous insufficiency
  • Ulcers requiring surgical revision in an operating room
  • Patent foramen ovale
  • More than three recurrences of venous ulcer
  • Body Mass Index greater than 40
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Helsinki University Central Hospital

Helsinki, Finland

Actively Recruiting

2

Keski-Suomen keskussairaala

Jyväskylä, Finland

Actively Recruiting

3

Oulu University Hospital

Oulu, Finland

Actively Recruiting

4

Turku University Hospital

Turku, Finland

Actively Recruiting

5

Vaasa Central Hospital

Vaasa, Finland

Actively Recruiting

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Research Team

M

Matti Pokela, Docent

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Toni Pihlaja, Pasi Ohtonen, Harri Hakovirta...

https://pubmed.ncbi.nlm.nih.gov/40243046