Clinical trial NCT06620120: Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles on the Symptoms and Quality of Life of Patients With Chronic Venous Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Disease
Quality of Life
Symptoms and Signs
Keywords: chronic venous disease, insoles, quality of life, symptom, relief
Lead sponsor: Millet Innovation
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.
* 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

Primary outcomes:
measure: Quality of life questionnaire
timeFrame: At Day 0 then Day 30 and Day 60
measure: Quality of life generic questionnaire
timeFrame: At Day 0 then Day 30 and Day 60
Secondary outcomes:
measure: Symptoms evaluation questionnaire
timeFrame: At Day 0 then Day 30 and Day 60
measure: Assessment of the 'ejection fraction' of the venous blood volume (ml)
timeFrame: At Day 0 then Day 30 and Day 60
measure: Leg Oedema evaluation
timeFrame: At Day 0 then Day 30 and Day 60
Other outcomes:
Locations:
city: Dole
country: France
facility: Centre Hospitalier Louis Pasteur
Study officials:
affiliation: Centre Hospitalier Louis Pasteur 39100 Dole
name: Samuel Beliard, Medical doctor
role: PRINCIPAL_INVESTIGATOR
References: