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

July 15, 2012 updated by: Galia Spectre, Hadassah Medical Organization

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.

Study Overview

Status

Unknown

Conditions

Post Thrombotic Syndrome

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Jerusalem, Israel, 12000
    - Hadassah Ein Karem Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: SUPPORTIVE_CARE
Interventional Model: CROSSOVER
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of life (Veins-QOL) Time Frame: 1 month	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

Principal Investigator: Galia Spectre, MD, Hematology departement, Haddash medical Center, Jerusalem, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ANTICIPATED)

July 1, 2013

Study Completion (ANTICIPATED)

July 1, 2013

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

July 8, 2012

First Posted (ESTIMATE)

July 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 15, 2012

Last Verified