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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2012 by Galia Spectre, Hadassah Medical Organization.
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

Galia Spectre, Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT01637428

First received: June 13, 2012

Last updated: July 15, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 13, 2012

Last Updated Date

July 15, 2012

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

July 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Quality of life (Veins-QOL) [ Time Frame: 1 month ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01637428 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Villalta Scale [ Time Frame: 1 month ]

The scale consists of five patient-rated venous symptoms (pain, cramps, heaviness, paresthesia, pruritus) and six clinician-rated physical signs (pretibial edema, skin induration, hyperpigmentation,pain during calf compression, venous ectasia, redness),which are each rated on a four-point scale (0 = none,1 = mild, 2 = moderate, 3 = severe). Points are summed to produce a total score (range: 0-33). Subjects are classified as having Post Thrombotic Syndrome if the score is 5 or more, or if a venous ulcer is present, in a leg with previous DVT.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care

Condition ^ICMJE

Post Thrombotic Syndrome

Intervention ^ICMJE

Device: ActiveCare+S.F.T 3rd generation

Intermittent Pneumatic Compression Device

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Israel

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01637428

Other Study ID Numbers ^ICMJE

727209-HMO-CTIL

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Galia Spectre, Hadassah Medical Organization

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Galia Spectre, MD

Hematology departement, Haddash medical Center, Jerusalem, Israel

PRS Account

Hadassah Medical Organization

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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