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

NCT06620120 | Completed

• 1 other identifier: 2023-A01923-42
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

chronic venous disease, insoles, quality of life, symptom, relief

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Symptoms evaluation questionnaire

  At Day 0 then Day 30 and Day 60

• Assessment of the 'ejection fraction' of the venous blood volume (ml)

  At Day 0 then Day 30 and Day 60

• Leg Oedema evaluation

  At Day 0 then Day 30 and Day 60

Study Arms (2)

One medical device as investigational device

EXPERIMENTAL

Device: Insoles

Without device

EXPERIMENTAL

Other: Without insoles

Interventions

Insoles 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.

One medical device as investigational device

Without insoles 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.

Without device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Millet Innovation: lead

Study Sites (1)

Centre Hospitalier Louis Pasteur

Dole, 39100, France

Location

MeSH Terms

Conditions

Signs and Symptoms

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Samuel Beliard, Medical doctor

  Centre Hospitalier Louis Pasteur 39100 Dole

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: October 1, 2024
• Study Start: November 1, 2023
• Primary Completion: February 11, 2024
• Study Completion: March 31, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

FR (1)