Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema. International, Multicentric, Randomised, Controlled, Double Blind Study, in Two Parallel Groups v0322 bc Versus Placebo

Conditions
-----------------
Chronic Venous Insufficiency (CVI)

Intervention / Treatment
-----------------
* Device: V0322 BC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years and above Permanent chronic oedema of venous origin (C3 based on CEAP classification) confirmed by Doppler or Duplex ultrasound examination with reflux and/or obstruction on superficial, deep or perforator veins Pitting oedema Have given and signed written informed consent Registered with or benefiting from health insurance (Mandatory for France) Exclusion Criteria: Use of compression therapy in the last 5 days before inclusion Common contraindications for MCT (arteriopathy, decompensated heart failure, infectious dermatitis Isolated lipoedema Isolated lymphoedema (Kaposi- Stemmer sign Severe systemic disease (heart failure, renal failure, hepatic failure, thyroid dysfunction untreated, malnutrition with hypo-proteinemia …) Known hypersensitivity to any component of MCT Important limitation of ankle movement requiring a specific therapy Following treatment initiated or dose-modified 1 month prior to inclusion: NSAID, corticosteroids, calcium blockers, ACE inhibitors, Angiotensin II inhibitors, vasoconstrictors or vasodilators Hormonal treatment initiated or dose-modified 1 month prior to inclusion Diuretic and/or phlebotonic treatment initiated or dose-modified 1 month prior to inclusion Pregnancy, breast feeding, planning to become pregnant, or not using any form of contraception Patient linguistically or psychologically unable to understand the information given or who refuses to give his/her consent in writing Participation in another clinical trial Deprived of liberty for administrative, medical and legal reasons May not be compliant with the constraints imposed by the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elastic Medical Compressive Therapy<br>V0322BC verum medical compressive therapy is a progressive compressive sock with: ankle pressure: 10 mmHg calf pressure : 23 mmHg | Device: V0322 BC<br>* 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<br>|
| Placebo Comparator: Placebo<br>V0322BC placebo medical compressive therapy is a progressive compressive sock with: ankle pressure: <5 mmHg calf pressure : <7 mmHg | Device: V0322 BC<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |