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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Galia Spectre, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637428
First Posted: July 11, 2012
Last Update Posted: July 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galia Spectre, Hadassah Medical Organization
June 13, 2012
July 11, 2012
July 17, 2012
July 2012
July 2013   (Final data collection date for primary outcome measure)
Quality of life (Veins-QOL) [ Time Frame: 1 month ]
Same as current
Complete list of historical versions of study NCT01637428 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome
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.
Not Provided
Interventional
Phase 2
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Post Thrombotic Syndrome
Device: ActiveCare+S.F.T 3rd generation
Intermittent Pneumatic Compression Device
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
July 2013
July 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01637428
727209-HMO-CTIL
Yes
Not Provided
Not Provided
Galia Spectre, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Galia Spectre, MD Hematology departement, Haddash medical Center, Jerusalem, Israel
Hadassah Medical Organization
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP