Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
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.
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}
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Postphlebitic Syndrome
Intervention
Veno-device (Venowave)
Location
Henderson Research Centre
Hamilton
Ontario
Canada
L8V 1C3
Status
Completed
Source
McMaster University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00182208
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Postphlebitic Syndrome
A condition characterized by a chronically swollen limb, often a leg with stasis dermatitis and ulcerations. This syndrome can appear soon after phlebitis or years later. Postphlebitic syndrome is the result of damaged or incompetent venous valves in the limbs. Distended, tortuous VARICOSE VEINS are usually present. Leg pain may occur after long period of standing.
Pulmonary Veno-occlusive Disease
Pathological process resulting in the fibrous obstruction of the small- and medium-sized PULMONARY VEINS and PULMONARY HYPERTENSION. Veno-occlusion can arise from fibrous proliferation of the VASCULAR INTIMA and VASCULAR MEDIA; THROMBOSIS; or a combination of both.
Safety-based Medical Device Withdrawals
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Medical Device Recalls
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
Intrauterine Device Migration
The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.
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