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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Symptoms and Signs; Venous Disease
• Intervention / Treatment: Device: Insoles; Other: Without insoles

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dole, France, 39100
    • Centre Hospitalier Louis Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One medical device as investigational device	Device: Insoles; 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.
Experimental: Without device	Other: Without insoles; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Millet Innovation
• Investigators: Principal Investigator: Samuel Beliard, Medical doctor, Centre Hospitalier Louis Pasteur 39100 Dole

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): February 11, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: chronic venous disease, insoles, quality of life, symptom, relief
• Other Study ID Numbers: 2023-A01923-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No