PainNCT01976637
Compression Treatment of Superficial Vein Thrombosis
A study testing no compression and compression in people with Pain and Erythema, run by Medical University of Vienna.
Trial summary
Leg compression is considered the basic treatment for superficial vein thrombosis (SVT). However, its use is more or less based on subjective experience while scientific evidence for its efficacy is lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Erythema, Thrombus Length
- What is being tested?
- no compression and compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Nov 2013
- 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
- patients with superficial vein thrombosis of the leg,
- thrombus extent of at least 5 cm confirmed by duplex sonography,
- clinical signs of inflammation (pain, erythema)
Who cannot join
- superficial thrombus distance to the saphenofemoral or saphenopopliteal junction of less than 2cm,
- concomitant deep vein thrombosis,
- thrombophilia,
- active malignoma,
- immobility,
- peripheral arterial occlusive disease,
Show all 9Show fewer
- superficial vein thrombosis after sclerotherapy
- incision and clot expression
- excessive leg configuration not covered by ready made compression stockings
About this study
Leg compression is considered the basic treatment for superficial vein thrombosis (SVT). However, its use is more or less based on subjective experience while scientific evidence for its efficacy is lacking. There is one uncontrolled trial reporting improvement of clinical symptoms when patients with SVT were treated with fixed compression bandages.
This study evaluates the efficacy of compression stockings (23-32 mmHg) in the treatment SVT of the legs. The investigators hypothesis is that compression treatment is superior to no compression in alleviating disease related clinical symptoms.
- Conditions
- Pain, Erythema, Thrombus Length, Quality of Life
- Being tested
- no compression, compression
- Medical subject headings
- Pain, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no compressionOther
no compression stockings worn during the study
compressionDevice
compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| no compression | Experimental | no compression stockings worn during a 3 weeks period Receives: Other: no compression |
| compression stockings | Active comparator | compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks Receives: Device: compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessed by VAS (cm)
change from baseline to week 3 at weekly intervals
Measured: at baseline, week 1, week 2, week 3
Secondary outcomes (6)
skin erythema (cm2)
change from baseline to week 3 at weekly intervals
Measured: at baseline, week 1, week 2, week 3
duplex-sonographic change in thrombus length (cm)
change from baseline to week 3 at weekly intervals
Measured: at baseline, week 1, week 2, week 3
quality of life (SF-36)
change from baseline to week 3
Measured: at baseline and at week 3
amount of analgetics (number of pills)
change from week 1 to week 3
Measured: week 1, week 2, week 3
duplex-sonographic confirmation of deep vein thrombosis
Measured: at baseline and at week 3
löwenberg test (mm Hg)
change from baseline to week 3
Measured: at baseline, week 1, week 2, week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startDec 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kornelia Boehler, Medical University of Vienna
- Investigators
- Kornelia Böhler, MD, Principal investigator, Medical University of Vienna, Department of General Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976637
- Sponsor's protocol ID
- EKNr 772/2009
- Status last verified
- Jan 2014
- First submitted
- 30 Oct 2013
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Treatment of Superficial Vein Thrombosis
- ClinicalTrials.gov ID
- NCT01976637
- Acronym / sponsor ID
- EKNr 772/2009
- Conditions
- Pain, Erythema, Thrombus Length, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Nov 2013 (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.
Leg compression is considered the basic treatment for superficial vein thrombosis (SVT). However, its use is more or less based on subjective experience while scientific evidence for its efficacy is lacking. There is one uncontrolled trial reporting improvement of clinical symptoms when patients with SVT were treated with fixed compression bandages.
This study evaluates the efficacy of compression stockings (23-32 mmHg) in the treatment SVT of the legs. The investigators hypothesis is that compression treatment is superior to no compression in alleviating disease related clinical symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no compression | Experimental | Other: no compressionno compression stockings worn during a 3 weeks period |
| compression stockings | Active comparator | Device: compressioncompression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with superficial vein thrombosis of the leg,
- thrombus extent of at least 5 cm confirmed by duplex sonography,
- clinical signs of inflammation (pain, erythema)
Key exclusion criteria (9 listed)
- superficial thrombus distance to the saphenofemoral or saphenopopliteal junction of less than 2cm,
- concomitant deep vein thrombosis,
- thrombophilia,
- active malignoma,
- immobility,
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 |
|---|---|---|
| no compressionno compression stockings worn during the study | Other | no compression |
| compressioncompression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks | Device | compression stockings |
Primary outcome
pain assessed by VAS (cm)
Time frame: at baseline, week 1, week 2, week 3
change from baseline to week 3 at weekly intervals
6 secondary outcomes
skin erythema (cm2)
Time frame: at baseline, week 1, week 2, week 3
duplex-sonographic change in thrombus length (cm)
Time frame: at baseline, week 1, week 2, week 3
quality of life (SF-36)
Time frame: at baseline and at week 3
amount of analgetics (number of pills)
Time frame: week 1, week 2, week 3
duplex-sonographic confirmation of deep vein thrombosis
Time frame: at baseline and at week 3
löwenberg test (mm Hg)
Time frame: at baseline, week 1, week 2, week 3
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 16 Jan 2014.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Kornelia Böhler, MD principal investigator
Medical University of Vienna, Department of General Dermatology
Questions about this trial
What is this clinical trial studying?
A study testing no compression and compression in people with Pain and Erythema, run by Medical University of Vienna.
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 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 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
pain assessed by VAS (cm) (time frame: at baseline, week 1, week 2, week 3). 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 16 Jan 2014; AzTrials last refreshed its copy on 7 Nov 2026.