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Status unknownNCT01637428Updated Jul 17, 2012

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

A Phase 2 interventional study of ActiveCare+S.F.T 3rd generation in Post Thrombotic Syndrome, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-07-17.

Sponsored by Hadassah Medical Organization · Phase 2, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Post Thrombotic Syndrome
03

In context

Postthrombotic Syndrome

67 studies on the registry are indexed under Postthrombotic Syndrome; 22 are open to participants now.

This study's planned enrollment of 20 is below the median of 88 across 41 interventional studies indexed under Postthrombotic Syndrome.

Browse Postthrombotic Syndrome studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 674 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • DeviceActiveCare+S.F.T 3rd generation

    Intermittent Pneumatic Compression Device

06

What researchers measure

Primary outcomes

  1. Quality of life (Veins-QOL)

    Time frame: 1 month

Secondary outcomes

  1. 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.

    Time frame: 1 month

07

Study locations

1 site
  • Hadassah Ein Karem Medical Center
    Jerusalem, 12000, Israel
    • Lemberg Hadas, PhD · Contact · lhadas@hadassah.org.il · +97226777572
    • Galia Spectre, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01637428
Responsible party
Galia Spectre (MD, Hadassah Medical Organization) — Principal investigator
First posted
Jul 11, 2012
Start date
Jul 2012
Primary completion
Jul 2013 (estimated)
Completion
Jul 2013 (estimated)
Last update
Jul 17, 2012

Study contacts

Galia Spectre, M.D
Contact
galias@hadassah.org.il
+97226779414
Hadas Lemberg, PhD
Contact
lhadas@hadassah.org.il
+97226777572
Galia Spectre, MD
principal investigator · Hematology departement, Haddash medical Center, Jerusalem, Israel

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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