Compression Treatment of Superficial Vein Thrombosis

Not Applicable

Completed

• Conditions: Pain; Erythema; Quality of Life; Thrombus Length
• Interventions: Device: compression; Other: no compression

• Registration Number: NCT01976637
• Lead Sponsor: Medical University of Vienna

Brief 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. 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2013-10-30
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-15
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
compression stockings	compression	compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
no compression	no compression	no compression stockings worn during a 3 weeks period

Primary Outcome Measures

Name	Time	Method
pain assessed by VAS (cm)	at baseline, week 1, week 2, week 3	change from baseline to week 3 at weekly intervals

Secondary Outcome Measures

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