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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT03618628
Eligibility Criteria:
Inclusion Criteria:
1. Daily life includes a minimum of moderate activity level (variable cadence walking)
2. Have a Gillette or carbon off loading orthosis as a result of diabetes related foot impairments
3. Diagnosis of diabetes mellitus and peripheral neuropathy
4. Ability to ambulate in the community (K-level ≥ 2)
5. Age \> 21 years
Exclusion Criteria:
1. Unable to ambulate and complete testing required for study participation.
2. Severe foot deformity of the hindfoot or any deformity of the foot with a dislocation resulting in a bony prominence on the plantar/weightbearing surface of the foot.
3. Neurological diseases that affects walking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03618628
Study Brief:
Protocol Section:
NCT03618628