Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
248 participants
INTERVENTIONAL
2021-02-26
2026-03-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Endothermal Ablation
Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)
Foam Sclerotherapy
Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.
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.
Endothermal Ablation
Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)
Foam Sclerotherapy
Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.
Interventions
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Endothermal Ablation
Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)
Foam Sclerotherapy
Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.
Eligibility Criteria
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Inclusion Criteria
* 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
* Ulcers requiring operation theater revision
* Patent foramen ovale
* Several times recurrent (over 3 recurrences) venous ulcer
* Body Mass Index over 40
* Pregnancy
18 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Oulu University Hospital
OTHER
Responsible Party
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Toni Pihlaja
Principal Investigator
Principal Investigators
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Toni Pihlaja, MD
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Karoliina Halmesmaki, Docent
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Maarit Venermo, Professor
Role: STUDY_CHAIR
Helsinki University Central Hospital
Matti Pokela, Docent
Role: STUDY_CHAIR
Oulu University Hospital
Locations
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Helsinki University Central Hospital
Helsinki, , Finland
Keski-Suomen keskussairaala
Jyväskylä, , Finland
Oulu University Hospital
Oulu, , Finland
Turku University Hospital
Turku, , Finland
Vaasa Central Hospital
Vaasa, , Finland
Countries
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Central Contacts
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Facility Contacts
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Tiia Kukkonen
Role: primary
References
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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.
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 Apr 17:2683555251335618. doi: 10.1177/02683555251335618. Online ahead of print.
Other Identifiers
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3/2021
Identifier Type: -
Identifier Source: org_study_id
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