Venous DiseaseNCT06620120
Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles on the Symptoms and Quality of Life of Patients With Chronic Venous Disease
A study testing Insoles and Without insoles in people with Venous Disease and Quality of Life, run by Millet Innovation at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Disease, Quality of Life, Symptoms and Signs
- What is being tested?
- Insoles and Without insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Insoles, Without insoles
- Keywords
- chronic venous disease, insoles, quality of life, symptom, relief
- Medical subject headings
- Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsolesDevice
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 insolesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| One medical device as investigational device | Experimental | Not described Receives: Device: Insoles |
| Without device | Experimental | Not described Receives: Other: Without insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: At Day 0 then Day 30 and Day 60
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At Day 0 then Day 30 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Nov 2023
- Primary completion11 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millet Innovation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Beliard, Medical doctor, Principal investigator, Centre Hospitalier Louis Pasteur 39100 Dole
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620120
- Sponsor's protocol ID
- 2023-A01923-42
- Status last verified
- Sep 2024
- First submitted
- 22 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06620120
- Acronym / sponsor ID
- 2023-A01923-42
- Conditions
- Venous Disease, Quality of Life, Symptoms and Signs
- Keywords
- chronic venous disease, insoles, quality of life, symptom, relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Millet InnovationIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 11 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One medical device as investigational device | Experimental | Device: Insoles |
| Without device | Experimental | Other: Without insoles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsolesAt 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. | Device | One medical device as investigational device |
| Without insolesAt 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. | Other | Without device |
Primary outcome
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.
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).
3 secondary outcomes
Symptoms evaluation questionnaire
Time frame: At Day 0 then Day 30 and Day 60
Assessment of the 'ejection fraction' of the venous blood volume (ml)
Time frame: At Day 0 then Day 30 and Day 60
Leg Oedema evaluation
Time frame: At Day 0 then Day 30 and Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Beliard, Medical doctor principal investigator
Centre Hospitalier Louis Pasteur 39100 Dole
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insoles and Without insoles in people with Venous Disease and Quality of Life, run by Millet Innovation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaire (time frame: At Day 0 then Day 30 and Day 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.