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

This study is not yet open for participant recruitment.

Verified July 2012 by Hadassah Medical Organization

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

Purpose

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.

Condition	Intervention	Phase
Post Thrombotic Syndrome	Device: ActiveCare+S.F.T 3rd generation	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Quality of life (Veins-QOL) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Villalta Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	20
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Intermittent Pneumatic Compression Device

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637428

Contacts

Contact: Galia Spectre, M.D	+97226779414	galias@hadassah.org.il
Contact: Hadas Lemberg, PhD	+97226777572	lhadas@hadassah.org.il

Locations

Israel
Hadassah Ein Karem Medical Center	Not yet recruiting
Jerusalem, Israel, 12000
Contact: Lemberg Hadas, PhD +97226777572 lhadas@hadassah.org.il
Principal Investigator: Galia Spectre, MD

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Galia Spectre, MD

Hematology departement, Haddash medical Center, Jerusalem, Israel

More Information

No publications provided

Responsible Party:	Galia Spectre, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT01637428 History of Changes
Other Study ID Numbers:	727209-HMO-CTIL
Study First Received:	June 13, 2012
Last Updated:	July 15, 2012
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Postthrombotic Syndrome
Postphlebitic Syndrome
Thrombosis
Venous Thrombosis
Embolism and Thrombosis

Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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