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Compression Treatment of Superficial Vein Thrombosis

Primary Purpose

Pain, Erythema, Thrombus Length

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
no compression
compression
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    no compression

    compression stockings

    Arm Description

    no compression stockings worn during a 3 weeks period

    compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks

    Outcomes

    Primary Outcome Measures

    pain assessed by VAS (cm)
    change from baseline to week 3 at weekly intervals

    Secondary Outcome Measures

    skin erythema (cm2)
    change from baseline to week 3 at weekly intervals
    duplex-sonographic change in thrombus length (cm)
    change from baseline to week 3 at weekly intervals
    quality of life (SF-36)
    change from baseline to week 3
    amount of analgetics (number of pills)
    change from week 1 to week 3
    duplex-sonographic confirmation of deep vein thrombosis
    löwenberg test (mm Hg)
    change from baseline to week 3

    Full Information

    First Posted
    October 30, 2013
    Last Updated
    January 15, 2014
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01976637
    Brief Title
    Compression Treatment of Superficial Vein Thrombosis
    Official Title
    Compression Treatment of Superficial Vein Thrombosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Erythema, Thrombus Length, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    no compression
    Arm Type
    Experimental
    Arm Description
    no compression stockings worn during a 3 weeks period
    Arm Title
    compression stockings
    Arm Type
    Active Comparator
    Arm Description
    compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
    Intervention Type
    Other
    Intervention Name(s)
    no compression
    Intervention Description
    no compression stockings worn during the study
    Intervention Type
    Device
    Intervention Name(s)
    compression
    Intervention Description
    compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
    Primary Outcome Measure Information:
    Title
    pain assessed by VAS (cm)
    Description
    change from baseline to week 3 at weekly intervals
    Time Frame
    at baseline, week 1, week 2, week 3
    Secondary Outcome Measure Information:
    Title
    skin erythema (cm2)
    Description
    change from baseline to week 3 at weekly intervals
    Time Frame
    at baseline, week 1, week 2, week 3
    Title
    duplex-sonographic change in thrombus length (cm)
    Description
    change from baseline to week 3 at weekly intervals
    Time Frame
    at baseline, week 1, week 2, week 3
    Title
    quality of life (SF-36)
    Description
    change from baseline to week 3
    Time Frame
    at baseline and at week 3
    Title
    amount of analgetics (number of pills)
    Description
    change from week 1 to week 3
    Time Frame
    week 1, week 2, week 3
    Title
    duplex-sonographic confirmation of deep vein thrombosis
    Time Frame
    at baseline and at week 3
    Title
    löwenberg test (mm Hg)
    Description
    change from baseline to week 3
    Time Frame
    at baseline, week 1, week 2, week 3
    Other Pre-specified Outcome Measures:
    Title
    D-dimer ug/ml
    Time Frame
    at baseline and at week 3
    Title
    platelet count
    Time Frame
    at baseline, day 7 and day14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kornelia Böhler, MD
    Organizational Affiliation
    Medical University of Vienna, Department of General Dermatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Compression Treatment of Superficial Vein Thrombosis

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