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

Primary Purpose

Post Thrombotic Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
ActiveCare+S.F.T 3rd generation
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Thrombotic Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Ein Karem Medical Center

Outcomes

Primary Outcome Measures

Quality of life (Veins-QOL)

Secondary Outcome Measures

Villalta Scale
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.

Full Information

First Posted
June 13, 2012
Last Updated
July 15, 2012
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01637428
Brief Title
The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome
Official Title
The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Thrombotic Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
ActiveCare+S.F.T 3rd generation
Intervention Description
Intermittent Pneumatic Compression Device
Primary Outcome Measure Information:
Title
Quality of life (Veins-QOL)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Villalta Scale
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Galia Spectre, M.D
Phone
+97226779414
Email
galias@hadassah.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lemberg, PhD
Phone
+97226777572
Email
lhadas@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galia Spectre, MD
Organizational Affiliation
Hematology departement, Haddash medical Center, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Ein Karem Medical Center
City
Jerusalem
ZIP/Postal Code
12000
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lemberg Hadas, PhD
Phone
+97226777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Galia Spectre, MD

12. IPD Sharing Statement

Learn more about this trial

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

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