Postphlebitic Syndrome
Conditions
Keywords
PTS, Post phlebitic Syndrome, Activities of Daily Living, Quality of Life
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 of life in subjects with severe PTS.
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 'wash out' period.( A randomized controlled 'crossover' study}
Interventions
DEVICEVeno-device (Venowave)
Sponsors
Health Canada
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Success measured with the Global Rating Instrument | — |
Secondary
| Measure | Time frame |
|---|---|
| PTS-CCS questionnaire | — |
| Villalta Scale | — |
| Veines Quality of Life Questionnaire | — |
Countries
Canada
Outcome results
None listed