Upward progressive versus degressive compressive stocking in patients with moderate to severe chronic venous insufficiency

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN80111329
• Date of registration: 03/01/2012
• Prospective Registration: No
• Primary sponsor: Pierre Fabre (France)
• Public title: Upward progressive versus degressive compressive stocking in patients with moderate to severe chronic venous insufficiency
• Scientific title: A randomised double-blind trial of upward progressive versus degressive compressive stocking in patients with moderate to severe chronic venous insufficiency
• Date of first enrolment: 27/06/2007
• Target sample size: 400
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN80111329
• Study type: Interventional
• Study design: Multicentre randomised double-blind parallel-group study (Treatment)
• Phase: Not Applicable

Countries of recruitment

France

Contacts

• Name: Serge Couzan

Key inclusion & exclusion criteria

Inclusion criteria: 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
Exclusion criteria: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic venous desease (or insufficiency)
Circulatory System
Venous insufficiency (chronic) (peripheral)

Intervention(s)

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

Primary Outcome(s)

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.

Secondary Outcome(s)

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

Secondary ID(s)

V00322 BC 401

Source(s) of Monetary Support

Pierre Fabre Laboratories (France)