Full-Leg vs Below-Knee Elastic Stockings for Prevention of the Post-Thrombotic Syndrome

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

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated compression (30-40 mm Hg at the ankle) elastic stocking for prevention of the post-thrombotic syndrome (PTS). All patients are followed up to three years to assess the development of the PTS, defined according to a validated clinical score (the Villalta scale). The rate of PTS is compared between the two study groups. In addition, there is an assessment of patients' compliance and tolerability of the two different devices.

Detailed Description

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Conditions

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Deep Vein Thrombosis

Keywords

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Deep vein thrombosis of the lower extremities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Elastic stockings

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* First episode of proximal deep vein thrombosis, as shown by compression ultrasound

Exclusion Criteria

* Previous ipsilateral deep vein thrombosis
* Preexisting chronic venous insufficiency
* Bilateral deep vein thrombosis
* Life expectancy lower than 1 year
* Severe arteriopathy of the lower limbs
* Known allergy to elastic stockings
* Lack of written informed consensus

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Department of Medical and Surgical Sciences, University of Padua

Principal Investigators

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Paolo Prandoni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical and Surgical Sciences, University of Padua, Italy

Locations

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Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua

Padua, Padua, Italy

Site Status

Countries

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Italy

References

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Prandoni P, Noventa F, Quintavalla R, Bova C, Cosmi B, Siragusa S, Bucherini E, Astorri F, Cuppini S, Dalla Valle F, Lensing AW, Prins MH, Villalta S; Canano Investigators. Thigh-length versus below-knee compression elastic stockings for prevention of the postthrombotic syndrome in patients with proximal-venous thrombosis: a randomized trial. Blood. 2012 Feb 9;119(6):1561-5. doi: 10.1182/blood-2011-11-391961. Epub 2011 Dec 16.

Reference Type DERIVED

PMID: 22180438 (View on PubMed)

Other Identifiers

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11/98

Identifier Type: -

Identifier Source: org_study_id