Compression Treatment of Superficial Vein Thrombosis

NCT ID: NCT01976637

Last Updated: 2014-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Erythema Thrombus Length Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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no compression

no compression stockings worn during a 3 weeks period

Group Type EXPERIMENTAL

no compression

Intervention Type OTHER

no compression stockings worn during the study

compression stockings

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

Group Type ACTIVE_COMPARATOR

compression

Intervention Type DEVICE

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

Interventions

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no compression

no compression stockings worn during the study

Intervention Type OTHER

compression

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Kornelia Boehler

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kornelia Böhler, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of General Dermatology

Other Identifiers

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EKNr 772/2009

Identifier Type: -

Identifier Source: org_study_id

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