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

Tracking Information
First Submitted Date ICMJE	June 13, 2012
First Posted Date ICMJE	July 11, 2012
Last Update Posted Date	July 17, 2012
Study Start Date ICMJE	July 2012
Estimated Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 8, 2012)	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; (submitted: July 8, 2012)	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; (submitted: July 8, 2012)	20
Original Estimated Enrollment ICMJE	Same as current
Estimated Study 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	No
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