Skip to main content
Clinical Trials/NCT01976637
NCT01976637
Completed
Not Applicable

Compression Treatment of Superficial Vein Thrombosis

Medical University of Vienna0 sites80 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Medical University of Vienna
Enrollment
80
Primary Endpoint
pain assessed by VAS (cm)
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
November 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kornelia Boehler

MD

Medical University of Vienna

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • amount of analgetics (number of pills)(week 1, week 2, 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)
  • quality of life (SF-36)(at baseline and at week 3)
  • löwenberg test (mm Hg)(at baseline, week 1, week 2, week 3)
  • duplex-sonographic change in thrombus length (cm)(at baseline, week 1, week 2, week 3)

Similar Trials