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| ID | Type | Description | Link |
|---|---|---|---|
| Health Canada No.:64844 |
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| Name | Class |
|---|---|
| Health Canada | OTHER_GOV |
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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 of life in subjects with severe PTS.
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 'wash out' period.( A randomized controlled 'crossover' study}
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veno-device (Venowave) | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success measured with the Global Rating Instrument |
| Measure | Description | Time Frame |
|---|---|---|
| PTS-CCS questionnaire | ||
| Villalta Scale | ||
| Veines Quality of Life Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin O'Donnell, MB MRCPI | Hamilton Health Sciences Corporation | Principal Investigator |
| Susan R Kahn, MD FRCPC | Department of Medicine McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henderson Research Centre | Hamilton | Ontario | L8V 1C3 | Canada | ||
| Sir Mortimer B. Davis Jewish General Hospital |
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| ID | Term |
|---|---|
| D011186 | Postphlebitic Syndrome |
| D054070 | Postthrombotic Syndrome |
| ID | Term |
|---|---|
| D010689 | Phlebitis |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Montreal |
| Quebec |
| H3T 1E2 |
| Canada |
| D014689 |
| Venous Insufficiency |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |