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

October 30, 2013
January 15, 2014
December 2009
November 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01976637 on ClinicalTrials.gov Archive Site
  • 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
Same as current
  • 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 ]
Same as current
 
Compression Treatment of Superficial Vein Thrombosis
Compression Treatment of Superficial Vein Thrombosis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain
  • Erythema
  • Thrombus Length
  • Quality of Life
  • 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
  • Experimental: no compression
    no compression stockings worn during a 3 weeks period
    Intervention: Other: no compression
  • Active Comparator: compression stockings
    compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
    Intervention: Device: compression
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01976637
EKNr 772/2009
Yes
Kornelia Boehler, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Kornelia Böhler, MD Medical University of Vienna, Department of General Dermatology
Medical University of Vienna
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP