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The main objective is to evaluate the effect of wearing the insoles developed by Millet Innovation on the symptoms and quality of life of patients suffering from chronic venous disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One medical device as investigational device | Experimental |
| |
| Without device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insoles | Device | At the D0 visit, if the patient is assigned to the arm with insoles. The patient completes the quality of life and symptom evaluation questionnaires, the plesthysmographic evaluation test, the analysis of walking without insoles and the oedema measurement. Then, at D30, the patient repeated the same tests, with the exception of the gait and plesthysmographic evaluation tests. The patient then switched to the other arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaire | CIVIQ (ChronIc Venous Insufficiency quality of life Questionnaire) 14 : It is a quality of life assessment scale comprising 14 items grouped into four main dimensions (pain, physical, psychological, social) with 5 levels (1 point (min) to 5 points (max)).The final score is between 14 and 70 points. A low score indicates a low impact of the disease on quality of life. | At Day 0 then Day 30 and Day 60 |
| Quality of life generic questionnaire | The 5-level EQ-5D version (EQ-5D-5L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1 point), to extreme problems (5 points). A low score indicates a low impact of the disease on quality of life. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' (100/100) and 'The worst health you can image' (0/100). | At Day 0 then Day 30 and Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms evaluation questionnaire | Veines-sym (VEinous INsefficency Epidemologic and Economic Study - Symptoms). 26-item Anglo-Saxon scale to explore symptoms, limitations in daily activities (physical and social dimensions) and the psychological impact of CVD. The final score is between 0 and 50 points. Higher values indicate better results. | At Day 0 then Day 30 and Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Beliard, Medical doctor | Centre Hospitalier Louis Pasteur 39100 Dole | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Louis Pasteur | Dole | 39100 | France |
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| Without insoles | Other | At the D0 visit, if the patient is assigned to the arm without insoles. The patient completes the quality of life and symptom evaluation questionnaires, the plesthysmographic evaluation test, the analysis of walking without insoles and the oedema measurement. Then, at D30, the patient repeated the same tests, with the exception of the gait and plesthysmographic evaluation tests. The patient then switched to the other arm. |
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| Assessment of the 'ejection fraction' of the venous blood volume (ml) | Strain-gauge plethysmography around the ankle. | At Day 0 then Day 30 and Day 60 |
| Leg Oedema evaluation | Assessment of leg oedema by a simple and reproducible method of assessing calf volume (cm3), which is calculated from the circumferential measurements of the ankles and calves and the height between the first and last circumference taken using a tape measure. | At Day 0 then Day 30 and Day 60 |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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