Compression Treatment of Superficial Vein Thrombosis

Study Overview
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Brief Summary
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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.

Official Title
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Compression Treatment of Superficial Vein Thrombosis

Conditions
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Pain, Erythema, Thrombus Length, Quality of Life

Intervention / Treatment
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* Other: no compression
* Device: compression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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, superficial vein thrombosis after sclerotherapy incision and clot expression excessive leg configuration not covered by ready made compression stockings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: no compression<br>no compression stockings worn during a 3 weeks period | Other: no compression<br>* no compression stockings worn during the study<br>|
| Active Comparator: compression stockings<br>compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks | Device: compression<br>* compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain assessed by VAS (cm) | change from baseline to week 3 at weekly intervals | at baseline, week 1, week 2, week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin erythema (cm2) | change from baseline to week 3 at weekly intervals | at baseline, week 1, week 2, week 3 | 
| duplex-sonographic change in thrombus length (cm) | change from baseline to week 3 at weekly intervals | at baseline, week 1, week 2, week 3 | 
| quality of life (SF-36) | change from baseline to week 3 | at baseline and at week 3 | 
| amount of analgetics (number of pills) | change from week 1 to week 3 | week 1, week 2, week 3 | 
| duplex-sonographic confirmation of deep vein thrombosis |  | at baseline and at week 3 | 
| löwenberg test (mm Hg) | change from baseline to week 3 | at baseline, week 1, week 2, week 3 |