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
Information provided by (Responsible Party):
Galia Spectre, Hadassah Medical Organization
First received: June 13, 2012
Last updated: July 15, 2012
Last verified: July 2012
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.
Post Thrombotic Syndrome
Device: ActiveCare+S.F.T 3rd generation
||Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637428
|Hadassah Ein Karem Medical Center
|Jerusalem, Israel, 12000 |
|Contact: Lemberg Hadas, PhD +97226777572 email@example.com |
|Principal Investigator: Galia Spectre, MD |
Hadassah Medical Organization
||Galia Spectre, MD
||Hematology departement, Haddash medical Center, Jerusalem, Israel
No publications provided
||Galia Spectre, MD, Hadassah Medical Organization
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 13, 2012
||July 15, 2012
||Israel: Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013
Embolism and Thrombosis
Peripheral Vascular Diseases