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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Hadassah Medical Organization

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

Original Primary Outcome: Same as current

Current Secondary Outcome: 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: Same as current

Information By: Hadassah Medical Organization

Dates:
Date Received: June 13, 2012
Date Started: July 2012
Date Completion: July 2013
Last Updated: July 15, 2012
Last Verified: July 2012