Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT06620120
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06620120
Study Brief:
Protocol Section:
NCT06620120