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:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT06627361
Eligibility Criteria:
Inclusion Criteria:
Adult patient (over 18 years of age)
* Unilateral tibial amputee and fitted for at least 6 months with a class III ESAR foot.
* Regularly using (more than 8 hours/day) a class III ESAR foot
* Functional class (CNEDiMTS indication)1
* Insured person.
* Able to answer questionnaires.
* Providing informed and written consent to participate in the study.
* Having a normalized PLUS-M/FC 12 score less than 50 for vascular amputee and 55 for traumatic amputee and other causes of amputation.
* Experiencing no discomfort related to the socket indicated by a score ≥ 6 on the numerical scale from 0 to 10 (Socket Comfort Score)
Exclusion Criteria:
* Bilateral lower limb amputation
* Femoral amputation
* Wearing a temporary prosthesis
* Change of socket or suspension system planned during the study.
* Change of any functional component as torsion or choc adapter
* Significant change in the patient's routine activities expected during the study.
* Progressive associated pathology that may prevent patient follow-up.
* Associated pathology that may limit the patient's mobility (e.g. disarticulation of the knee, knee pain... )
* No osteointegration patients
* Lack of consent
* Adult subject to enhanced protection, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research.
* Person not affiliated with or a beneficiary of a health insurance plan.
* Patient unable to understand the study instructions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06627361
Study Brief:
Protocol Section:
NCT06627361