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

NCT ID: NCT06620120

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-03-31

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.

Conditions

Venous Disease; Quality of Life; Symptoms and Signs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One medical device as investigational device

Group Type: EXPERIMENTAL

Insoles

Intervention Type: DEVICE

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.

Without device

Group Type: EXPERIMENTAL

Without insoles

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millet Innovation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Beliard, Medical doctor

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Louis Pasteur 39100 Dole

Locations

Centre Hospitalier Louis Pasteur

Dole, , France

Countries

France

Other Identifiers

2023-A01923-42

Identifier Type: -

Identifier Source: org_study_id