Compression Treatment of Superficial Vein Thrombosis

January 15, 2014 updated by: Kornelia Boehler, Medical University of Vienna

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain assessed by VAS (cm)
Time Frame: at baseline, week 1, week 2, week 3
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)
Time Frame: at baseline, week 1, week 2, week 3
change from baseline to week 3 at weekly intervals
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
change from baseline to week 3 at weekly intervals
at baseline, week 1, week 2, week 3
quality of life (SF-36)
Time Frame: at baseline and at week 3
change from baseline to week 3
at baseline and at week 3
amount of analgetics (number of pills)
Time Frame: week 1, week 2, week 3
change from week 1 to week 3
week 1, week 2, week 3
duplex-sonographic confirmation of deep vein thrombosis
Time Frame: at baseline and at week 3
at baseline and at week 3
löwenberg test (mm Hg)
Time Frame: at baseline, week 1, week 2, week 3
change from baseline to week 3
at baseline, week 1, week 2, week 3

Other Outcome Measures

Outcome Measure
Time Frame
D-dimer ug/ml
Time Frame: at baseline and at week 3
at baseline and at week 3
platelet count
Time Frame: at baseline, day 7 and day14
at baseline, day 7 and day14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Kornelia Böhler, MD, Medical University of Vienna, Department of General Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (ESTIMATE)

November 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNr 772/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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