Evaluating foam sclerotherapy for venous leg ulcers
Finnish Venous Ulcer Study
This study tests if getting foam sclerotherapy right away can help people with venous leg ulcers heal faster compared to the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oulu University Hospital Academic / other |
| Locations | 5 sites (Helsinki and 4 other locations) |
| Trial ID | NCT04737941 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial assesses the effectiveness of first-visit foam sclerotherapy in patients with venous leg ulcers. Participants are randomly assigned to receive either immediate foam sclerotherapy or the current standard treatment. Both groups will also undergo endothermal ablation and/or foam sclerotherapy in subsequent visits to address underlying venous insufficiency. The primary outcome measured is the time taken for the ulcers to heal over a one-year follow-up period.
Who should consider this trial
Good fit: Ideal candidates are patients aged one month to one year with venous ulcers and verified superficial venous insufficiency.
Not a fit: Patients with leg ulcers of non-venous origin or those requiring surgical intervention will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the healing time for patients with venous leg ulcers.
How similar studies have performed: Previous studies have shown promising results with foam sclerotherapy for venous ulcers, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki and 4 other locations
- Helsinki University Central Hospital — Helsinki, Finland (Recruiting)
- Keski-Suomen keskussairaala — Jyväskylä, Finland (Recruiting)
- Oulu University Hospital — Oulu, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
- Vaasa Central Hospital — Vaasa, Finland (Recruiting)
Study contacts
- Principal investigator: Toni Pihlaja, MD — Oulu University Hospital
- Study coordinator: Matti Pokela, Docent
- Email: matti.pokela@ppshp.fi
- Phone: 083152011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.