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OpenTrials
Completed

NCT Number: NCT01976637

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.

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Key information

Conditions

Pain Erythema Neurologic Manifestations Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Thrombus Length

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no compression

Other

no compression stockings worn during the study

compression

Device

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

Primary outcomes

  1. 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

  1. skin erythema (cm2)

    Time frame: at baseline, week 1, week 2, week 3

    change from baseline to week 3 at weekly intervals

  2. 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

  3. quality of life (SF-36)

    Time frame: at baseline and at week 3

    change from baseline to week 3

  4. amount of analgetics (number of pills)

    Time frame: week 1, week 2, week 3

    change from week 1 to week 3

  5. duplex-sonographic confirmation of deep vein thrombosis

    Time frame: at baseline and at week 3

  6. löwenberg test (mm Hg)

    Time frame: at baseline, week 1, week 2, week 3

    change from baseline to week 3

Other outcomes

  1. D-dimer ug/ml

    Time frame: at baseline and at week 3

  2. platelet count

    Time frame: at baseline, day 7 and day14

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 6, 2013
Registry last updated
Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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