The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome

NCT ID: NCT01637428

Last Updated: 2012-07-17

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-07-31

Brief Summary

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The use of ActiveCare+S.F.T 3rd generation (an Intermittent Pneumatic Compression Device) will improve quality of life in patients suffering from Post Thrombotic Syndrome compared to compression stockings which is the current gold standard of care.

Detailed Description

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Conditions

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Post Thrombotic Syndrome

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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ActiveCare+S.F.T 3rd generation

Intermittent Pneumatic Compression Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients who have developed post Thrombotic leg symptoms after a deep vein thrombosis event.

Exclusion Criteria

* admitted patients
* Patients who suffer from peripheral artery disease.
* Patients with an acute deep vein thrombosis.
* s/p leg skin transplant
* Patients with an active leg infection
* Patients who aren't capable of operating the device.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Galia Spectre

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Galia Spectre, MD

Role: PRINCIPAL_INVESTIGATOR

Hematology departement, Haddash medical Center, Jerusalem, Israel

Locations

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Hadassah Ein Karem Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Galia Spectre, M.D

Role: CONTACT

Phone: +97226779414

Email: [email protected]

Hadas Lemberg, PhD

Role: CONTACT

Phone: +97226777572

Email: [email protected]

Facility Contacts

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Lemberg Hadas, PhD

Role: primary

Other Identifiers

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727209-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id