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ISRCTN
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ISRCTN80111329
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ClinicalTrials.gov identifier
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Public title
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Upward progressive versus digressive compressive stocking in patients with moderate to severe chronic venous insufficiency
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Scientific title
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A randomised double-blind trial of upward progressive versus digressive compressive stocking in patients with moderate to severe chronic venous insufficiency
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Acronym
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N/A
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Serial number at source
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V00322 BC 401
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Study hypothesis
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There is a higher impact on clinical symptoms in patients suffering moderate to severe chronic venous desease
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Lay summary
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Lay summary under review
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Ethics approval
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Committee to Protect People "Southeast I", University Hospital of Saint-Etienne [Comité de Protection des Personnes "Sud-Est I", Centre Hospitalier Universitaire de Saint-Etienne], 12 March 2007, ref: 2007-11 JV 2007/97
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Study design
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Multicentre randomised double-blind parallel group study
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Countries of recruitment
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France
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Disease/condition/study domain
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Chronic venous desease (or insufficiency)
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Participants - inclusion criteria
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1. Male or female adult outpatients
2. Presenting current pain and/or heavy legs due to moderate to severe chronic venous insufficiency (CEAP C2b to C5)
3. Eligible for a 30 mmHg compressive therapy
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Participants - exclusion criteria
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1. Bandage therapy recommended
2. Current use of a compressive stocking >30 mmHg
3. Active ulcer
4. Deep vein thrombosis or pulmonary embolism in the past three months
5. Arterial disease of the lower limb
6. Non-venous oedema
7. Inflammatory, dermatologic or traumatic disorder of a lower limb
8. Known hypersensitivity to components of the study compressive stockings
9. Surgery or vascular procedure in the past month or planned in the next three months
10. Poor life expectancy
11. Inability to walk
12. Pregnancy
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Anticipated start date
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27/06/2007
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Anticipated end date
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25/09/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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400
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Interventions
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Group Progressive NS : progressive compressive stockings (10 mmHg at ankle, 23 mmHg at upper calf)
For each of treatment arms the method and frequency of administration, and the total duration of treatment and follow-up products wear every day (weak-up to sleep) during 6 months
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Primary outcome measure(s)
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Evaluation after three months of treatment - improvement of pain or heavy legs, without onset of either ulcer, deep or superficial vein thrombosis of the lower limb, or pulmonary embolism.
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Secondary outcome measure(s)
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1. Compliance
2. Easiness of use
3. Discomfort/harm related to the compressive stockings at months one, three and six
4. Improvement or worsening of pain or heavy legs was evaluated using four-level Likert scales
5. Interviews concerning intercurrent venous or adverse events, compliance, easiness to apply, and discomfort/harm related to the stockings.
6. At month three, a physical examination was performed and CEAP and modified Venous Clinical Severity Score (VCSS) were evaluated
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Sources of funding
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Pierre Fabre Laboratories (France)
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Trial website
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Publications
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Contact name
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Dr
Serge
Couzan
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Address
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104 rue Bergson
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City/town
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Saint Etienne
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Zip/Postcode
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42000
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Country
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France
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Sponsor
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Pierre Fabre (France)
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Address
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c/o Mr Xavier Saudez
29 Avenue du Sidobre
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City/town
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Castres
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Zip/Postcode
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81106
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Country
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France
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Sponsor website:
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http://www.pierre-fabre.com/
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Date applied
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27/10/2011
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Last edited
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03/01/2012
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Date ISRCTN assigned
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03/01/2012
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