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Clinical Trials/NCT01637428
NCT01637428UnknownPhase 2

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

Hadassah Medical Organization2 sites in 1 country20 target enrollmentStarted: July 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Enrollment
20
Locations
2
Primary Endpoint
Quality of life (Veins-QOL)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Quality of life (Veins-QOL)

Time Frame: 1 month

Secondary Outcomes

  • Villalta Scale(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Galia Spectre

MD

Hadassah Medical Organization

Study Sites (2)

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