Status:
COMPLETED
Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Health Canada
Conditions:
Postphlebitic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave', improves leg symptoms, ability to perform activities of daily living, and quality o...
Detailed Description
Eligible consenting patients will be randomly allocated to receive either the veno-device (active or placebo for 8 weeks and crossed over for a further 8 weeks (active or placebo) following a 4 week '...
Eligibility Criteria
Inclusion
- Past History of objectively documented deep vein thrombosis
- Daily leg swelling with discomfort (i.e. report at least one of the following symptoms: heavy legs, aching legs and/or throbbing) for a minimum of 6 months
- Over 18 years of age (and of either gender).
- Villalta score of greater than 14(i.e.severe post phlebitic syndrome)
Exclusion
- Episode of objectively documented deep vein thrombosis occurred less than 6 months before recruitment
- Subjects report that their symptoms have been unstable (worsening, improving or variable over the previous month).
- Active venous ulceration
- Baseline leg circumference greater than 50 cm (cuff will not fit subject)
- Symptomatic peripheral arterial disease Peripheral neuropathy
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00182208
Start Date
May 1 2004
End Date
December 1 2005
Last Update
July 22 2008
Active Locations (2)
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1
Henderson Research Centre
Hamilton, Ontario, Canada, L8V 1C3
2
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2