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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Galia Spectre, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01637428
First received: June 13, 2012
Last updated: July 15, 2012
Last verified: July 2012

June 13, 2012
July 15, 2012
July 2012
July 2013   (final data collection date for primary outcome measure)
Quality of life (Veins-QOL) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01637428 on ClinicalTrials.gov Archive Site
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.
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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.
 
Not yet recruiting
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.
Both
18 Years to 80 Years
No
Contact: Galia Spectre, M.D +97226779414 galias@hadassah.org.il
Contact: Hadas Lemberg, PhD +97226777572 lhadas@hadassah.org.il
Israel
 
NCT01637428
727209-HMO-CTIL
Yes
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