Varicose VeinsNCT02890563
Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
A study testing Class II Compression Stockings in people with Varicose Veins, run by Oulu University Hospital at 2 sites in Finland.
Trial summary
Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Class II Compression Stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesFinland
- Study dates
- Aug 2016to Mar 2019
- 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
- Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
- Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
- Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation
Who cannot join
- History of pulmonary embolism or deep venous thrombosis
- Large (>12mm) truncal vein diameter
- CEAP C5-C6
- Patient unwilling to participate
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Oulu University Hospital, Vascular Department
Oulu, 90220
Raahe's hospital
Raahe, North Ostrobothnia, 92101
About this study
Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II)
Read the detailed description
In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group.
Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage.
Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.
- Conditions
- Varicose Veins
- Being tested
- Class II Compression Stockings
- Keywords
- Varicose veins, Compression stockings, Sclerotherapy, Radiofrequency ablation
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Class II Compression StockingsDevice
| Study group | Role | What they receive |
|---|---|---|
| No Compression | No intervention | Patients in this group will not receive any compression after treatment. |
| Compression | Active comparator | Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime). Receives: Device: Class II Compression Stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Truncal vein occlusion rate
Measured: 6 months
Secondary outcomes (6)
Post-operative pain assessed with visual analogue scale (VAS)
Measured: 10 days
Painkillers usage after treatment
Need for Paracetamol/NSAIDs after treatment
Measured: 10 days
Aberdeen Varicose Veins Questionnaire (AVVQ)
Assessed preoperatively and at one and six months
Measured: 6 months
Compliance with compression stockings
To assess compliance and possible reasons for non-compliance at compression group
Measured: 7 days
Time required returning to normal work and activity level
Measured: 14 days
Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively
Assessed in 1month control and earlier if necessary (Patient is instructed to contact outpatient clinic in case of problems).
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2019
- Study completionMar 2019
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 Varicose VeinsStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toni Pihlaja, Oulu University Hospital
- Investigators
- Toni Pihlaja, M.D., Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890563
- Sponsor's protocol ID
- 131/2016
- Status last verified
- Mar 2019
- First submitted
- 31 Aug 2016
- Last updated
- 1 Apr 2019
- Results posted
- No
Publications
Pihlaja T, Romsi P, Ohtonen P, Jounila J, Pokela M. Post-procedural Compression vs. No Compression After Radiofrequency Ablation and Concomitant Foam Sclerotherapy of Varicose Veins: A Randomised Controlled Non-inferiority Trial. Eur J Vasc Endovasc Surg. 2020 Jan;59(1):73-80. doi: 10.1016/j.ejvs.2019.08.020. Epub 2019 Nov 18.
PubMed 31753745
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
- ClinicalTrials.gov ID
- NCT02890563
- Acronym / sponsor ID
- 131/2016
- Conditions
- Varicose Veins
- Keywords
- Varicose veins, Compression stockings, Sclerotherapy, Radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II)
Detailed description
In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group.
Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage.
Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Compression | No intervention | –Patients in this group will not receive any compression after treatment. |
| Compression | Active comparator | Device: Class II Compression StockingsPatients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
- Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
- Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation
Key exclusion criteria (4 listed)
- History of pulmonary embolism or deep venous thrombosis
- Large (>12mm) truncal vein diameter
- CEAP C5-C6
- Patient unwilling to participate
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 |
|---|---|---|
| Class II Compression Stockings | Device | Compression |
Primary outcome
Truncal vein occlusion rate
Time frame: 6 months
6 secondary outcomes
Post-operative pain assessed with visual analogue scale (VAS)
Time frame: 10 days
Painkillers usage after treatment
Time frame: 10 days
Aberdeen Varicose Veins Questionnaire (AVVQ)
Time frame: 6 months
Compliance with compression stockings
Time frame: 7 days
Time required returning to normal work and activity level
Time frame: 14 days
Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively
Time frame: 30days
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 1 Apr 2019.
- Derived from this study: PubMed 31753745Pihlaja T, Romsi P, Ohtonen P, Jounila J, Pokela M. Post-procedural Compression vs. No Compression After Radiofrequency Ablation and Concomitant Foam Sclerotherapy of Varicose Veins: A Randomised Controlled Non-inferiority Trial. Eur J Vasc Endovasc Surg. 2020 Jan;59(1):73-80. doi: 10.1016/j.ejvs.2019.08.020. Epub 2019 Nov 18.
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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, M.D. principal investigator
Oulu University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Class II Compression Stockings in people with Varicose Veins, run by Oulu University Hospital at 2 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 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Truncal vein occlusion rate (time frame: 6 months). 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 NCT02890563, 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 1 Apr 2019.