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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT03164356
Eligibility Criteria:
Inclusion Criteria:
* Transtibial amputees, unilateral or bilateral
* Amputation at least 18 months prior
* Walking activity of at least 7 hours per week
* Medicare functional classification level of 2 or higher
* Residual limb length of at least 9 centimeters
* Detrimental impacts to socket fit caused by residual limb volume fluctuations
* Indication for augmented suspension, socket modification/change, sock application removal or activity modification
Exclusion Criteria:
* Incidence of skin breakdown
* Inability to ambulate continuously on a level walkway
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03164356
Study Brief:
Protocol Section:
NCT03164356