Compression Treatment of Superficial Vein Thrombosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kornelia Boehler, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01976637
First received: October 30, 2013
Last updated: January 15, 2014
Last verified: January 2014
  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: Open Label
Primary Purpose: Treatment
Official Title: Compression Treatment of Superficial Vein Thrombosis

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • pain assessed by VAS (cm) [ Time Frame: at baseline, week 1, week 2, week 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    change from baseline to week 3 at weekly intervals

  • quality of life (SF-36) [ Time Frame: at baseline and at week 3 ] [ Designated as safety issue: No ]
    change from baseline to week 3

  • amount of analgetics (number of pills) [ Time Frame: week 1, week 2, week 3 ] [ Designated as safety issue: No ]
    change from week 1 to week 3

  • duplex-sonographic confirmation of deep vein thrombosis [ Time Frame: at baseline and at week 3 ] [ Designated as safety issue: Yes ]
  • löwenberg test (mm Hg) [ Time Frame: at baseline, week 1, week 2, week 3 ] [ Designated as safety issue: No ]
    change from baseline to week 3


Other Outcome Measures:
  • D-dimer ug/ml [ Time Frame: at baseline and at week 3 ] [ Designated as safety issue: No ]
  • platelet count [ Time Frame: at baseline, day 7 and day14 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01976637

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

No publications provided

Responsible Party: Kornelia Boehler, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01976637     History of Changes
Other Study ID Numbers: EKNr 772/2009
Study First Received: October 30, 2013
Last Updated: January 15, 2014
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on July 22, 2014