NCT01637428

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

June 13, 2012

Last Update Submit

July 15, 2012

Conditions

Post Thrombotic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Quality of life (Veins-QOL)

    1 month

Secondary Outcomes (1)

  • Villalta Scale

    1 month

Interventions

ActiveCare+S.F.T 3rd generationDEVICE

Intermittent Pneumatic Compression Device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have developed post Thrombotic leg symptoms after a deep vein thrombosis event.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Ein Karem Medical Center

Jerusalem, 12000, Israel

Location

MeSH Terms

Conditions

Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVenous Insufficiency

Study Officials

  • Galia Spectre, MD

    Hematology departement, Haddash medical Center, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Galia Spectre, M.D

CONTACT

+97226779414galias@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

+97226777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 13, 2012

First Posted

July 11, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

IL(1)