Venous InsufficiencyNCT01298908
Comparison of Treatments in Venous Insufficiency
A study testing Operative treatment, Laser ablation and Foam sclerotherapy in people with Venous Insufficiency, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers. The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Operative treatment, Laser ablation and Foam sclerotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 2 sitesFinland
- Study dates
- Oct 2007to Dec 2015
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with chronic superficial vein insufficiency
- patient must be 20-70 years old
- degree of difficulty of vein insufficiency C2-C4
- average diameter of refluxing great saphenous vein 4 -10 mm
- patient is agreeable to the study
Who cannot join
- peripheral atherosclerotic occlusive disease
- lymphoedema
- severe concomitant disease
- venous ulcers or unclassified skin changes
- BMI more than 40
- pregnancy
Show all 9Show fewer
- allergy to the foam used in sclerotherapy or to local anaesthetics
- coagulation disorder
- bilateral vein insufficiency (equal symptoms)
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki, HUS, 00029
Department of Vascular Surgery, Tampere University Hospital
Tampere, 33521
About this study
Official title: The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency
Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.
The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.
Read the detailed description
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.
- Conditions
- Venous Insufficiency
- Being tested
- Operative treatment, Laser ablation, Foam sclerotherapy
- Keywords
- varicose veins, oedema
- Medical subject headings
- Venous Insufficiency, Varicose Veins, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative treatmentProcedure or surgery
Also called Vein stripping
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.
Laser ablationProcedure or surgery
Also called Ultrasound guided laser ablation
In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein.
Foam sclerotherapyProcedure or surgery
Also called Ultrasound guided foam sclerotherapy
Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control.
| Study group | Role | What they receive |
|---|---|---|
| Operative treatment | Other | vein stripping Receives: Procedure: Operative treatment |
| Laser ablation | Other | Ultrasound guided laser ablation Receives: Procedure: Laser ablation |
| Foam sclerotherapy | Other | Ultrasound guided foam sclerotherapy Receives: Procedure: Foam sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization or reflux of the treated venous trunk
Results will be verified by Duplex scanning
Measured: at 1 and 12 months
Secondary outcomes (3)
Symptom relief
Symptoms will be evaluated by using CEAP-classification and degree of disability
Measured: at 1 and 12 months
Complications related to procedure
At 1 month follow-up immediate complications will be recorded. At 12 months follow-up appearance of late complications and pain and incapacity for work due to the procedure will be recorded.
Measured: at 1 and 12 months
Quality of life
Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life)
Measured: at 1 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startOct 2007
- Primary completionDec 2012
- Study completionDec 2015
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 InsufficiencyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarit Venermo, Helsinki University Central Hospital
- Investigators
- Maarit Venermo, MD,PhD, Study director, Department of Vascular Surgery, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298908
- Sponsor's protocol ID
- Version 1.0 - Sep 6th, 2006
- Status last verified
- Jan 2016
- First submitted
- 17 Feb 2011
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vahaaho S, Halmesmaki K, Alback A, Saarinen E, Venermo M. Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins. Br J Surg. 2018 May;105(6):686-691. doi: 10.1002/bjs.10757.
PubMed 29652086
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency
- ClinicalTrials.gov ID
- NCT01298908
- Acronym / sponsor ID
- Version 1.0 - Sep 6th, 2006
- Conditions
- Venous Insufficiency
- Keywords
- varicose veins, oedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Feb 2011 (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.
Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.
The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.
Detailed description
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Operative treatment | Other | Procedure: Operative treatmentvein stripping |
| Laser ablation | Other | Procedure: Laser ablationUltrasound guided laser ablation |
| Foam sclerotherapy | Other | Procedure: Foam sclerotherapyUltrasound guided foam sclerotherapy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with chronic superficial vein insufficiency
- patient must be 20-70 years old
- degree of difficulty of vein insufficiency C2-C4
- average diameter of refluxing great saphenous vein 4 -10 mm
- patient is agreeable to the study
Key exclusion criteria (9 listed)
- peripheral atherosclerotic occlusive disease
- lymphoedema
- severe concomitant disease
- venous ulcers or unclassified skin changes
- BMI more than 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 |
|---|---|---|
| Operative treatmentAlso: Vein strippingIn operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. | Procedure or surgery | Operative treatment |
| Laser ablationAlso: Ultrasound guided laser ablationIn intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. | Procedure or surgery | Laser ablation |
| Foam sclerotherapyAlso: Ultrasound guided foam sclerotherapyUltrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. | Procedure or surgery | Foam sclerotherapy |
Primary outcome
Recanalization or reflux of the treated venous trunk
Time frame: at 1 and 12 months
Results will be verified by Duplex scanning
3 secondary outcomes
Symptom relief
Time frame: at 1 and 12 months
Complications related to procedure
Time frame: at 1 and 12 months
Quality of life
Time frame: at 1 and 12 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 8 Jan 2016.
- Derived from this study: PubMed 29652086Vahaaho S, Halmesmaki K, Alback A, Saarinen E, Venermo M. Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins. Br J Surg. 2018 May;105(6):686-691. doi: 10.1002/bjs.10757.
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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.
Maarit Venermo, MD,PhD study director
Department of Vascular Surgery, Helsinki University Central 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 Operative treatment, Laser ablation and Foam sclerotherapy in people with Venous Insufficiency, run by Helsinki University Central 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 5 inclusion and 9 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 8 Jan 2016. 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?
Recanalization or reflux of the treated venous trunk (time frame: at 1 and 12 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 NCT01298908, 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 8 Jan 2016.