Chronic venous desease (or insufficiency) Circulatory System Venous insufficiency (chronic) (peripheral)
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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