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Completed

NCT Number: NCT06620120

Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles 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.

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Key information

Conditions

Venous Disease Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Symptoms and Signs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Louis Pasteur

Dole, 39100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Quality of life questionnaire

    Time frame: 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.

  2. Quality of life generic questionnaire

    Time frame: 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).

Secondary outcomes

  1. Symptoms evaluation questionnaire

    Time frame: 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.

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

    Time frame: At Day 0 then Day 30 and Day 60

    Strain-gauge plethysmography around the ankle.

  3. Leg Oedema evaluation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Millet Innovation

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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