Single-centre, Prospective, Randomised, Controlled, Study to Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles by Millet Innovation on the Symptoms and Quality of Life of Patients With Chronic Venous Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Venous Disease
- Sponsor
- Millet Innovation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Quality of life generic questionnaire
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic venous disease at CEAP C2S stage - the S means that patients must be symptomatic
- •Women or men aged over 18
- •Good general state of health
- •High or average level of activity estimated by the GAPQ questionnaire
- •Patient able to understand the requirements of the trial and having signed a free and informed consent prior to study entry
- •Patient able to read and understand written instructions
- •Patient able to complete the self-assessment questionnaires
- •Patient with a foot size between 36 and 44
Exclusion Criteria
- •Low level of activity estimated by the GAPQ questionnaire
- •Cardiac, inflammatory, liver, kidney and arterial disease
- •Subject with non-venous oedema
- •Subject with an open wound on the foot
- •Subject unable to attend all 3 visits
- •Patients unable to comply with the constraints of the protocol, in particular patients whose mental state does not allow them to understand the nature, objectives and possible consequences of the study.
- •Pregnant or breastfeeding women or women who are expecting to become pregnant during the study.
- •Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent
- •Adults subject to a legal protection measure or unable to express their consent
- •Any other reason which, in the opinion of the investigator, could interfere with the proper conduct of the study.
Outcomes
Primary Outcomes
Quality of life generic questionnaire
Time Frame: At Day 0 then Day 30 and Day 60
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).
Quality of life questionnaire
Time Frame: At Day 0 then Day 30 and Day 60
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.
Secondary Outcomes
- Assessment of the 'ejection fraction' of the venous blood volume (ml)(At Day 0 then Day 30 and Day 60)
- Symptoms evaluation questionnaire(At Day 0 then Day 30 and Day 60)
- Leg Oedema evaluation(At Day 0 then Day 30 and Day 60)