Venous Leg UlcerNCT04737941
Finnish Venous Ulcer Study (FINNULCER Study)
A study testing Endothermal Ablation and Foam Sclerotherapy in people with Venous Leg Ulcer, run by Oulu University Hospital at 5 sites in Finland.
Trial summary
This multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Endothermal Ablation and Foam Sclerotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 5 sitesFinland
- Study dates
- 26 Feb 2021to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Helsinki University Central Hospital
Helsinki
Keski-Suomen keskussairaala
Jyväskylä
Oulu University Hospital
Oulu
Turku University Hospital
Turku
Vaasa Central Hospital
Vaasa
About this study
Official title: Finnish Venous Ulcer Study
This multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer.
Read the 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).
- Conditions
- Venous Leg Ulcer
- Being tested
- Endothermal Ablation, Foam Sclerotherapy
- Keywords
- Venous Leg Ulcer, Foam Sclerotherapy, Endothermal Ablation, Sub-ulcer Foam Sclerotherapy
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothermal AblationProcedure or surgery
Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)
Foam SclerotherapyProcedure or surgery
Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.
| Study group | Role | What they receive |
|---|---|---|
| First-visit foam sclerotherapy | Experimental | 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. Receives: Procedure: Endothermal Ablation; Procedure: Foam Sclerotherapy |
| Scheduled treatment | Active comparator | 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. Receives: Procedure: Endothermal Ablation; Procedure: Foam Sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ulcer Healing
Complete re-epithelialisation of ulcer area
Measured: 0-365 days
Secondary outcomes (3)
EQ-5D Questionnaire
Score 0-100 where higher is better
Measured: 0-365 days
Wound-QOL Questionnaire
Score 0-17 where lower is better
Measured: 0-365 days
Venous ulcer area
Reduction on venous ulcer maximum diameter
Measured: 0-365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start26 Feb 2021
- Primary completion1 Aug 2025
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Principal investigator, Toni Pihlaja, Oulu University Hospital
- Investigators
- Toni Pihlaja, MD, Principal investigator, Oulu University HospitalKaroliina Halmesmaki, Docent, Principal investigator, Helsinki University Central HospitalMaarit Venermo, Professor, Study chair, Helsinki University Central HospitalMatti Pokela, Docent, Study chair, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737941
- Sponsor's protocol ID
- 3/2021
- Status last verified
- Oct 2026
- First submitted
- 30 Jan 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33248300Pihlaja 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.
PubMed 40243046
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish Venous Ulcer Study
- ClinicalTrials.gov ID
- NCT04737941
- Acronym / sponsor ID
- 3/2021
- Conditions
- Venous Leg Ulcer
- Keywords
- Venous Leg Ulcer, Foam Sclerotherapy, Endothermal Ablation, Sub-ulcer Foam Sclerotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-visit foam sclerotherapy | Experimental | Procedure: Endothermal Ablation, Procedure: Foam SclerotherapyPatients 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. |
| Scheduled treatment | Active comparator | Procedure: Endothermal Ablation, Procedure: Foam SclerotherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endothermal AblationEndothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein) | Procedure or surgery | First-visit foam sclerotherapy, Scheduled treatment |
| Foam SclerotherapyFoam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins. | Procedure or surgery | First-visit foam sclerotherapy, Scheduled treatment |
Primary outcome
Time to ulcer Healing
Time frame: 0-365 days
Complete re-epithelialisation of ulcer area
3 secondary outcomes
EQ-5D Questionnaire
Time frame: 0-365 days
Wound-QOL Questionnaire
Time frame: 0-365 days
Venous ulcer area
Time frame: 0-365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 33248300Pihlaja 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.
- Derived from this study: PubMed 40243046Pihlaja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toni Pihlaja, MD principal investigator
Oulu University Hospital
Karoliina Halmesmaki, Docent principal investigator
Helsinki University Central Hospital
Maarit Venermo, Professor study chair
Helsinki University Central Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endothermal Ablation and Foam Sclerotherapy in people with Venous Leg Ulcer, run by Oulu University Hospital at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ulcer Healing (time frame: 0-365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737941, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.