Varicose Veins of Lower LimbNCT03613376
Compression And Functional Ability After Endovenous Varicose Vein Treatment
A study testing Class II compression stockings in people with Varicose Veins of Lower Limb and Varicose Veins, run by Oulu University Hospital at 1 site in Finland.
Trial summary
Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins of Lower Limb, Varicose Veins
- What is being tested?
- Class II compression stockings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteFinland
- Study dates
- 21 May 2018to 1 Jan 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duplex ultrasound verified GSV, AASV and/or SSV incompetence suitable for radiofrequency ablation
- Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
- Distal varicose vein insufficiency suitable for sclerotherapy
- Patient willingness to participate
Who cannot join
- History of pulmonary embolism or deep venous thrombosis
- Large (>12mm) truncal vein diameter
- CEAP C5-C6
- Antithrombotic medication (ASA accepted)
Trial locations and contacts
1 site in 1 country.
About this study
Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group (Group II)
- Conditions
- Varicose Veins of Lower Limb, 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 stockingsOther
Patients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime
| 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 class II compression stockings continuously until next evening and then next 4 days during daytime. Receives: Other: Class II compression stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Visual Analog Scale (VAS) 0-100mm
Measured: 10days recorded daily
Secondary outcomes (8)
Functional ability, other than pain
Visual Analog Scale 0-100mm indicating post-operative functional ability reduction
Measured: 10 days recorded daily
Aberdeen Varicose Veins Questionnaire (AVVQ)
Score from 0 to 99.658
Measured: Assessed preoperatively and at 2 months
Visual appearance of varicose veins, patient assessment
Patient self-assessment (Patient Self-Assessment of Visible Varicose Veins, PA-V score)
Measured: Preoperatively and at 2 months
Signs of deep venous thrombosis hematoma
Ultrasound assessment
Measured: Assessed at 2 months and earlier if necessary
Time required returning to normal activity
Measured: 14 days
Time required returning to full activity
Measured: 14 days
Postoperative pigmentation
Pigmentation is monitored from standardised photographs on severity of pigmentation and most severe tone of post-operative pigmentation compared to base skin colour, reviewers are blinded to study group.
Measured: at 2 months
Visual appearance of varicose veins, expert assessment
Photography Review -Visible Varicose Veins (IPR-V score, reviewers are blinded to time point and study group).
Measured: Preoperatively and at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start21 May 2018
- Primary completion21 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins of Lower LimbStudies 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
- 109 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
- NCT03613376
- Sponsor's protocol ID
- 97/2018
- Status last verified
- Jan 2021
- First submitted
- 27 May 2018
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression And Functional Ability After Endovenous Varicose Vein Treatment
- ClinicalTrials.gov ID
- NCT03613376
- Acronym / sponsor ID
- 97/2018
- Conditions
- Varicose Veins of Lower Limb, Varicose Veins
- Keywords
- Varicose veins, Compression stockings, Sclerotherapy, Radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 3 Aug 2018 (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.
Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group (Group II)
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 | Other: Class II compression stockingsPatients in this group will use class II compression stockings continuously until next evening and then next 4 days during daytime. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Duplex ultrasound verified GSV, AASV and/or SSV incompetence suitable for radiofrequency ablation
- Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
- Distal varicose vein insufficiency suitable for sclerotherapy
- Patient willingness to participate
Key exclusion criteria (4 listed)
- History of pulmonary embolism or deep venous thrombosis
- Large (>12mm) truncal vein diameter
- CEAP C5-C6
- Antithrombotic medication (ASA accepted)
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 stockingsPatients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime | Other | Compression |
Primary outcome
Post-operative pain
Time frame: 10days recorded daily
Visual Analog Scale (VAS) 0-100mm
8 secondary outcomes
Functional ability, other than pain
Time frame: 10 days recorded daily
Aberdeen Varicose Veins Questionnaire (AVVQ)
Time frame: Assessed preoperatively and at 2 months
Visual appearance of varicose veins, patient assessment
Time frame: Preoperatively and at 2 months
Signs of deep venous thrombosis hematoma
Time frame: Assessed at 2 months and earlier if necessary
Time required returning to normal activity
Time frame: 14 days
Time required returning to full activity
Time frame: 14 days
Postoperative pigmentation
Time frame: at 2 months
Visual appearance of varicose veins, expert assessment
Time frame: Preoperatively and at 2 months
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 20 Jan 2021.
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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 Class II compression stockings in people with Varicose Veins of Lower Limb and Varicose Veins, 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 4 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 20 Jan 2021. 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?
Post-operative pain (time frame: 10days recorded daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2021.