Venous UlcerNCT03795064
Immediate Versus Early Endovenous Ablation In Venous Ulcer
A study testing Foam sclerotherapy and Endothermal ablation in people with Venous Ulcer, run by Oulu University Hospital at 1 site in Finland.
Trial summary
The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- Foam sclerotherapy and Endothermal ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFinland
- Study dates
- 5 Dec 2018to 30 Aug 2023
- 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
- Venous ulcer > 1 month
- Ulcer area > 1cm2
- Palpable distal pulses / Ankle-brachial index > 0,8 / Toe-brachial index > 70mmhg (at least one criteria must be met)
Who cannot join
- Leg ulcers other than venous etiology
- Pregnancy
- General contraindications for foam sclerotherapy
- Ulcers requiring operation theater revision
Trial locations and contacts
1 site in 1 country.
About this study
The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.
Read the detailed description
Recently EVRA study showed that early endovenous ablation (foam sclerotherapy and/or endothermal ablation) is beneficial for venous ulcer healing. This randomized controlled trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit to vascular outpatient clinic (immediate intervention). Patients in control group will receive foam sclerotherapy at four weeks (early intervention). Endothermal ablation is performed in early setting in both groups when truncal vein anatomy is suitable. The primary outcome for this study is the reduction of venous ulcer area at four weeks.
- Conditions
- Venous Ulcer
- Being tested
- Foam sclerotherapy, Endothermal ablation
- Keywords
- Venous Ulcer, Venous Insufficiency of Leg, Varicose Veins
- Medical subject headings
- Varicose Ulcer, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam sclerotherapyProcedure or surgery
Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.
Endothermal ablationProcedure or surgery
Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention). Receives: Procedure: Foam sclerotherapy; Procedure: Endothermal ablation |
| Early Intervention | Active comparator | Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention). Receives: Procedure: Foam sclerotherapy; Procedure: Endothermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous ulcer area
Venous ulcer area measured from calibrated digital photograph.
Measured: 0 to 180 days
Secondary outcomes (2)
Time to ulcer healing
Complete re-epithelialisation of ulcer area.
Measured: 0 to 360 days
Total time of active venous ulcer
Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.
Measured: 0 to 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start5 Dec 2018
- Primary completion30 Jan 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toni Pihlaja, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795064
- Sponsor's protocol ID
- 268/2018
- Status last verified
- Apr 2024
- First submitted
- 4 Jan 2019
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pihlaja T, Ohtonen P, Romsi P, Pokela M. Sub-ulcer foam sclerotherapy in patients with venous ulceration: A randomized controlled trial. Phlebology. 2025 Jun;40(5):324-329. doi: 10.1177/02683555241304030. Epub 2024 Nov 27.
PubMed 39601296
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Early Endovenous Ablation In Venous Ulcer
- ClinicalTrials.gov ID
- NCT03795064
- Acronym / sponsor ID
- 268/2018
- Conditions
- Venous Ulcer
- Keywords
- Venous Ulcer, Venous Insufficiency of Leg, Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 7 Jan 2019 (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.
The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.
Detailed description
Recently EVRA study showed that early endovenous ablation (foam sclerotherapy and/or endothermal ablation) is beneficial for venous ulcer healing. This randomized controlled trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit to vascular outpatient clinic (immediate intervention). Patients in control group will receive foam sclerotherapy at four weeks (early intervention). Endothermal ablation is performed in early setting in both groups when truncal vein anatomy is suitable. The primary outcome for this study is the reduction of venous ulcer area at four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Procedure: Foam sclerotherapy, Procedure: Endothermal ablationPatients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention). |
| Early Intervention | Active comparator | Procedure: Foam sclerotherapy, Procedure: Endothermal ablationPatients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Venous ulcer > 1 month
- Ulcer area > 1cm2
- Palpable distal pulses / Ankle-brachial index > 0,8 / Toe-brachial index > 70mmhg (at least one criteria must be met)
Key exclusion criteria (4 listed)
- Leg ulcers other than venous etiology
- Pregnancy
- General contraindications for foam sclerotherapy
- Ulcers requiring operation theater revision
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 |
|---|---|---|
| Foam sclerotherapyFoam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area. | Procedure or surgery | Early Intervention, Immediate Intervention |
| Endothermal ablationEndothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable. | Procedure or surgery | Early Intervention, Immediate Intervention |
Primary outcome
Venous ulcer area
Time frame: 0 to 180 days
Venous ulcer area measured from calibrated digital photograph.
2 secondary outcomes
Time to ulcer healing
Time frame: 0 to 360 days
Total time of active venous ulcer
Time frame: 0 to 360 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 3 Apr 2024.
- Derived from this study: PubMed 39601296Pihlaja T, Ohtonen P, Romsi P, Pokela M. Sub-ulcer foam sclerotherapy in patients with venous ulceration: A randomized controlled trial. Phlebology. 2025 Jun;40(5):324-329. doi: 10.1177/02683555241304030. Epub 2024 Nov 27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foam sclerotherapy and Endothermal ablation in people with Venous Ulcer, run by Oulu University Hospital at 1 site 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 3 inclusion and 4 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 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Venous ulcer area (time frame: 0 to 180 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 NCT03795064, which also lists 1 linked publication.
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 3 Apr 2024.