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

A randomised double-blind trial of upward progressive versus degressive compressive stocking in patients with moderate to severe chronic venous insufficiency

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN80111329
Enrollment
400
Registered
2012-01-03
Start date
2007-06-27
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 tre

Sponsors

Pierre Fabre (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026