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Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004). Item C3 of this classification relates to patients suffering from chronic venous disease and permanent oedema. Literature mentions only one study in which volume reduction in venous-induced oedema was primary endpoint. Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a Class 2 compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible quantitative measure considered nowadays as being gold standard when objectifying oedema variation. It is therefore particularly relevant in a C3-patient trial (CEAP classification).
The main objective of the current study is to evaluate the clinical effect of Progressiv' MCT on volume reduction in permanent CVI-oedema after 3 months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elastic Medical Compressive Therapy | Experimental | V0322BC verum medical compressive therapy is a progressive compressive sock with:
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| Placebo | Placebo Comparator | V0322BC placebo medical compressive therapy is a progressive compressive sock with:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V0322 BC | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Volume reduction of the target leg presenting the most important initial volume (by Volumetry using water displacement) | The main criterion is defined as the target leg volume reduction of chronic venous oedema measured by volumetry method with water displacement at 3 months | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional symptoms by VAS (pain, heaviness) at each visit by the patient. | 0-Day 7-Day 30 and Day 90 | |
| Quality of life. SQOR-V and ABC-V (FARDEAU) score | 0-Day 7-Day 30 and Day 90 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalo-Universitaire Grenoble | Grenoble | Isère | 38000 | France |
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| Body weight variation |
| 0-Day 7-Day 30 and Day 90 |
| Suprafacial Thickness Measured Duplex measurement | 0-Day 7-Day 30 and Day 90 |
| Assessment of local tolerance (examination of the skin) and safety (general clinical examination and reported adverse events) | Day 7-Day 30 and Day 90 |