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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01976637
Other study ID # EKNr 772/2009
Secondary ID
Status Completed
Phase N/A
First received October 30, 2013
Last updated January 15, 2014
Start date December 2009
Est. completion date November 2013

Study information

Verified date January 2014
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
no compression
no compression stockings worn during the study
Device:
compression
compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Outcome

Type Measure Description Time frame Safety issue
Other D-dimer ug/ml at baseline and at week 3
Other platelet count at baseline, day 7 and day14
Primary pain assessed by VAS (cm) change from baseline to week 3 at weekly intervals at baseline, week 1, week 2, week 3
Secondary skin erythema (cm2) change from baseline to week 3 at weekly intervals at baseline, week 1, week 2, week 3
Secondary duplex-sonographic change in thrombus length (cm) change from baseline to week 3 at weekly intervals at baseline, week 1, week 2, week 3
Secondary quality of life (SF-36) change from baseline to week 3 at baseline and at week 3
Secondary amount of analgetics (number of pills) change from week 1 to week 3 week 1, week 2, week 3
Secondary duplex-sonographic confirmation of deep vein thrombosis at baseline and at week 3
Secondary löwenberg test (mm Hg) change from baseline to week 3 at baseline, week 1, week 2, week 3
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