Varicose Vein DiseaseNCT01103258
FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins
A study testing high ligation and stripping (surgery) and FOAM in people with Varicose Vein Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Varicose vein disease is a common health problem, which causes much discomfort to patients. Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Vein Disease
- What is being tested?
- high ligation and stripping (surgery) and FOAM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2006to Jan 2010
- 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
- incompetence of great saphenous vein for minimal 20 cm
- life expectancy at least 3 years
- open and competent deep venous system
- willing to undergo both treatments
Who cannot join
- active ulcer
- signs of deep venous thrombosis with duplex
- incompetence of the deep venous system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study
Varicose vein disease is a common health problem, which causes much discomfort to patients.
Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population.
Choice of treatment often depends on the referral preference of the General Practitioner. Until now data are missing which treatment is more cost effective. The current proposal aims at comparing the effects, costs and patient preferences between duplex guided foam sclerotherapy and surgery in the treatment of greater varicose veins.
- Conditions
- Varicose Vein Disease
- Being tested
- high ligation and stripping (surgery), FOAM
- Keywords
- Incompetence of the great saphenous vein.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high ligation and stripping (surgery)Procedure or surgery
surgery consisting of high ligation in combination with long saphenous stripping
FOAMProcedure or surgery
duplex guided foam sclerotherapy
| Study group | Role | What they receive |
|---|---|---|
| high ligation and stripping | Active comparator | surgery consisting of high ligation in combination with long saphenous stripping Receives: Procedure: high ligation and stripping (surgery) |
| duplex guided foam sclerotherapy | Active comparator | duplex guided foam sclerotherapy Receives: Procedure: FOAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative probability of recurrent varicose vein within 24 months after treatment
Measured: 24 months
Secondary outcomes (3)
quality of life (as measured by EuroQol-5D)
Measured: 24 months
patient preferences (as measured by conjoint analysis)
Measured: 24 months
direct Health care costs
materials, operation costs, personnel costs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startFeb 2006
- Primary completionDec 2009
- Study completionJan 2010
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 Vein DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- A Sommer, MD PhD, Study director, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103258
- Sponsor's protocol ID
- MEC 05-2-014
- Other IDs
- ZON MW 4636
- Status last verified
- Apr 2010
- First submitted
- 6 Apr 2010
- Last updated
- 14 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, van Neer P, vd Kley J, de Haan E, Sommer A. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012 Aug;99(8):1062-70. doi: 10.1002/bjs.8781. Epub 2012 May 25.
PubMed 22627969
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01103258
- Acronym / sponsor ID
- MEC 05-2-014
- Conditions
- Varicose Vein Disease
- Keywords
- Incompetence of the great saphenous vein.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Feb 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Apr 2010 (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.
Varicose vein disease is a common health problem, which causes much discomfort to patients.
Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population.
Choice of treatment often depends on the referral preference of the General Practitioner. Until now data are missing which treatment is more cost effective. The current proposal aims at comparing the effects, costs and patient preferences between duplex guided foam sclerotherapy and surgery in the treatment of greater varicose veins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high ligation and stripping | Active comparator | Procedure: high ligation and stripping (surgery)surgery consisting of high ligation in combination with long saphenous stripping |
| duplex guided foam sclerotherapy | Active comparator | Procedure: FOAMduplex guided foam sclerotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- incompetence of great saphenous vein for minimal 20 cm
- life expectancy at least 3 years
- open and competent deep venous system
- willing to undergo both treatments
Key exclusion criteria (3 listed)
- active ulcer
- signs of deep venous thrombosis with duplex
- incompetence of the deep venous system
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 |
|---|---|---|
| high ligation and stripping (surgery)surgery consisting of high ligation in combination with long saphenous stripping | Procedure or surgery | high ligation and stripping |
| FOAMduplex guided foam sclerotherapy | Procedure or surgery | duplex guided foam sclerotherapy |
Primary outcome
cumulative probability of recurrent varicose vein within 24 months after treatment
Time frame: 24 months
3 secondary outcomes
quality of life (as measured by EuroQol-5D)
Time frame: 24 months
patient preferences (as measured by conjoint analysis)
Time frame: 24 months
direct Health care costs
Time frame: 24 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 14 Apr 2010.
- Derived from this study: PubMed 22627969Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, van Neer P, vd Kley J, de Haan E, Sommer A. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012 Aug;99(8):1062-70. doi: 10.1002/bjs.8781. Epub 2012 May 25.
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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.
A Sommer, MD PhD study director
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high ligation and stripping (surgery) and FOAM in people with Varicose Vein Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 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 14 Apr 2010. 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 Netherlands. 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?
cumulative probability of recurrent varicose vein within 24 months after treatment (time frame: 24 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 NCT01103258, 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 14 Apr 2010.