Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial

Hamilton Health Sciences (HHS)

Status and phase

Completed

Phase 3

Conditions

Postphlebitic Syndrome

Treatments

Device: Veno-device (Venowave)

Study type

Interventional

Funder types

Other

Identifiers

NCT00182208

Health Canada No.:64844

CTMG-2005-VENOPTS

Details and patient eligibility

About

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.

Full 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}

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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