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

Post Thrombotic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01637428
• Other study ID #: 727209-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 13, 2012
• Last updated: July 15, 2012
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2012
• Source: Hadassah Medical Organization
• Contact: Galia Spectre, M.D
• Phone: +97226779414
• Email: galias[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Post Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome

Intervention

Device:
• ActiveCare+S.F.T 3rd generation
Intermittent Pneumatic Compression Device

Locations

Country	Name	City	State
Israel	Hadassah Ein Karem Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (Veins-QOL)		1 month	No
Secondary	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.	1 month	No