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

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): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Galia Spectre, M.D; Phone Number: +97226779414; Email: galias@hadassah.org.il
• Study Contact Backup: Name: Hadas Lemberg, PhD; Phone Number: +97226777572; Email: lhadas@hadassah.org.il

Study Locations

• Israel
  • Jerusalem, Israel, 12000
    • Hadassah Ein Karem Medical Center
    • Contact: Lemberg Hadas, PhD; Phone Number: +97226777572; Email: lhadas@hadassah.org.il
    • Principal Investigator: Galia Spectre, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• 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

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)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Villalta Scale	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

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Galia Spectre, MD, Hematology departement, Haddash medical Center, Jerusalem, Israel

Study record dates

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: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Syndrome; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: 727209-HMO-CTIL