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

Not Applicable

Completed

• Conditions: Venous Disease; Quality of Life; Symptoms and Signs
• Interventions: Device: Insoles; Other: Without insoles

• Registration Number: NCT06620120
• Lead Sponsor: Millet Innovation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-02-11
• Study Completion: 2024-03-31
• Study First Submitted: 2024-08-22
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
One medical device as investigational device	Insoles	-
Without device	Without insoles	-

Primary Outcome Measures

Name	Time	Method
Quality of life generic questionnaire	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	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 Outcome Measures

Name	Time	Method
Symptoms evaluation questionnaire	At Day 0 then Day 30 and Day 60	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.
Assessment of the 'ejection fraction' of the venous blood volume (ml)	At Day 0 then Day 30 and Day 60	Strain-gauge plethysmography around the ankle.
Leg Oedema evaluation	At Day 0 then Day 30 and Day 60	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.

Trial Locations

Locations (1)

Centre Hospitalier Louis Pasteur; 🇫🇷 Dole, France