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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT06432335
Eligibility Criteria:
Inclusion Criteria:
\-
Prosthesis Users:
Aims 1 and 2
* Over 18 years of age
* Unilateral or bilateral trans-tibial amputation at least 12 months prior
* Have a limb of length 9 cm or greater
* Are capable of at least 5 minutes of continuous walking
* Regularly use a definitive prosthesis
* Do not regularly use assistive devices (e.g., cane, walker) for ambulation
* Do not have open wounds on their residual limb at the time of enrollment
Aim 2
-Regularly visit their prosthetist at least twice a year,
Exclusion Criteria:
\-
Prosthesis Users:
Aims 1 and 2
* Reduced skin sensation
* Presence of skin breakdown
* Regular use of an assistive device
* Persons with trans-femoral amputation
Aim 1 Only
-Vacuum suspension users
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06432335
Study Brief:
Protocol Section:
NCT06432335