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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
* Stocking 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). * The medical device is defined by the following parameters: ankle pressure(10 mmHg)and calf pressure (23 mmHg) * 3 months duration daily treatment
Centre Hospitalo-Universitaire Grenoble
Grenoble, Isère, France
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
Time frame: Day 90
Functional symptoms by VAS (pain, heaviness) at each visit by the patient.
Time frame: 0-Day 7-Day 30 and Day 90
Quality of life. SQOR-V and ABC-V (FARDEAU) score
Time frame: 0-Day 7-Day 30 and Day 90
Body weight variation
Time frame: 0-Day 7-Day 30 and Day 90
Suprafacial Thickness Measured Duplex measurement
Time frame: 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)
Time frame: Day 7-Day 30 and Day 90
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