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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT03717233
Eligibility Criteria:
Inclusion Criteria:
* Self-reported history of diabetic foot ulcer
Exclusion Criteria:
* Unable to continuously ambulate/walk ≥ 40 feet without an assistive device, such as a cane or walker
* Signs/symptoms of an infected foot lesion/ulcer as determined by a basic foot exam
* Trans-metatarsal foot amputation or more significant amputation.
* Symptomatic for signs/symptoms of cardiovascular disease as determined from interpretation of the 2017 PAR-Q+ (predicated on participant responses of "yes" indicating symptomatic/unstable medical conditions to page 2 and page 3 of the 2017 PAR-Q)
* Participants will be excluded from this study if they demonstrate pre-participation, or chronic, signs/symptoms of hypoglycemia: Confusion, unusual headache, unusual visual disturbances, self-reported mental dullness, shakiness, self-reported weakness, abnormal sweating, undue nervousness/anxiety, and/or tingling of the mouth, toes, and/or fingers or if they answer yes to question 5b and 5c of the 2017 PAR-Q+ .
* Participants will be temporarily excluded from this study if they are symptomatic for acute illness such as cold or fever. If the participant is symptomatic for acute illness such as cold or fever, participation will be reconsidered upon illness resolution.
* If participants answer yes to question 4a of the 2017 PAR-Q+ and if they demonstrate pre-study participation resting blood pressure \< 90/60 mmHg and \>140/90 mmHg .
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03717233
Study Brief:
Protocol Section:
NCT03717233