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
  Purpose

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.


Condition Intervention Phase
Post Thrombotic Syndrome
Device: ActiveCare+S.F.T 3rd generation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome

Further study details as provided by Hadassah Medical Organization:

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: 20
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ActiveCare+S.F.T 3rd generation
    Intermittent Pneumatic Compression Device
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637428

Contacts
Contact: Galia Spectre, M.D +97226779414 galias@hadassah.org.il
Contact: Hadas Lemberg, PhD +97226777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Ein Karem Medical Center Not yet recruiting
Jerusalem, Israel, 12000
Contact: Lemberg Hadas, PhD    +97226777572    lhadas@hadassah.org.il   
Principal Investigator: Galia Spectre, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Galia Spectre, MD Hematology departement, Haddash medical Center, Jerusalem, Israel
  More Information

No publications provided

Responsible Party: Galia Spectre, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01637428     History of Changes
Other Study ID Numbers: 727209-HMO-CTIL
Study First Received: June 13, 2012
Last Updated: July 15, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Postthrombotic Syndrome
Postphlebitic Syndrome
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014