Compression Treatment of Superficial Vein Thrombosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: no compression no compression stockings worn during a 3 weeks period |
Other: no compression
no compression stockings worn during the study
|
| Active Comparator: compression stockings compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks |
Device: compression
compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
|
Outcome Measures
Primary Outcome Measures
- 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
- skin erythema (cm2) [at baseline, week 1, week 2, week 3]
change from baseline to week 3 at weekly intervals
- duplex-sonographic change in thrombus length (cm) [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
- 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]
- löwenberg test (mm Hg) [at baseline, week 1, week 2, week 3]
change from baseline to week 3
Other Outcome Measures
- D-dimer ug/ml [at baseline and at week 3]
- platelet count [at baseline, day 7 and day14]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Kornelia Böhler, MD, Medical University of Vienna, Department of General Dermatology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EKNr 772/2009