Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles on the Symptoms and Quality of Life of Patients With Chronic Venous Disease

Millet Innovation

Status

Completed

Conditions

Quality of Life

Symptoms and Signs

Venous Disease

Treatments

Other: Without insoles

Device: Insoles

Study type

Interventional

Funder types

Industry

Identifiers

NCT06620120

2023-A01923-42

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
Patient unable to wear shoes with a drop of less than 2.5cm for the duration of the study
Subject already wearing orthopaedic insoles or standard insoles