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Compression Treatment of Superficial Vein Thrombosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01976637
First Posted: November 6, 2013
Last Update Posted: January 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kornelia Boehler, Medical University of Vienna
  Purpose

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 Intervention
Pain Erythema Thrombus Length Quality of Life Other: no compression Device: compression

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compression Treatment of Superficial Vein Thrombosis

Resource links provided by NLM:


Further study details as provided by Kornelia Boehler, Medical University of Vienna:

Primary Outcome Measures:
  • pain assessed by VAS (cm) [ Time Frame: at baseline, week 1, week 2, week 3 ]
    change from baseline to week 3 at weekly intervals


Secondary Outcome Measures:
  • skin erythema (cm2) [ Time Frame: at baseline, week 1, week 2, week 3 ]
    change from baseline to week 3 at weekly intervals

  • 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

  • quality of life (SF-36) [ Time Frame: at baseline and at week 3 ]
    change from baseline to week 3

  • amount of analgetics (number of pills) [ Time Frame: week 1, week 2, week 3 ]
    change from week 1 to week 3

  • duplex-sonographic confirmation of deep vein thrombosis [ Time Frame: 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


Other Outcome Measures:
  • D-dimer ug/ml [ Time Frame: at baseline and at week 3 ]
  • platelet count [ Time Frame: at baseline, day 7 and day14 ]

Enrollment: 80
Study Start Date: December 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976637


Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Kornelia Böhler, MD Medical University of Vienna, Department of General Dermatology
  More Information

Responsible Party: Kornelia Boehler, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01976637     History of Changes
Other Study ID Numbers: EKNr 772/2009
First Submitted: October 30, 2013
First Posted: November 6, 2013
Last Update Posted: January 16, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Erythema
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Skin Diseases