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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT02329366
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age ≥ 18
* Type 2 Diabetes
* A break in the skin on the foot ≥ 0.5cm2 and is Grade 1 or 2 as defined by the Wagner grading system
* Hemoglobin A1c ≥ 5.9%
* Ability to provide written informed consent
Exclusion Criteria:
* Any experimental drugs taken orally or topically within 4 weeks of study entry
* Malignant disease at/or in proximity to the DFU
* Target wound of malignant origin
* Failure to satisfy at least one inclusion criterion for one of the two study groups.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02329366
Study Brief:
Protocol Section:
NCT02329366