The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome
- Conditions
- Post Thrombotic Syndrome
- Registration Number
- NCT01637428
- Lead Sponsor
- Hadassah Medical Organization
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- patients who have developed post Thrombotic leg symptoms after a deep vein thrombosis event.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Quality of life (Veins-QOL) 1 month
- Secondary Outcome Measures
Name Time Method Villalta Scale 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.
Trial Locations
- Locations (1)
Hadassah Ein Karem Medical Center
🇮🇱Jerusalem, Israel