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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT02202668
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide informed consent
* Diagnosis of diabetes mellitus
* Full thickness or superficial foot and ankle ulcers based on clinical assessment (e.g., University of Texas (UT) grades 1-3, stages A-D). For reference, see Appendix 1 for the UT classification table
Exclusion Criteria:
* Age less than 18 or greater than 80 years old
* Subject has a psychological or sociological condition or an addictive disorder that would preclude informed consent
* Completely epithelialized ulcer based on clinical assessment with no ischemia or infection (UT classification 0A)
* Current or previous use of anti-resorptive bisphosphonate drugs (e.g., risedronate (Actonel) and alendronate (Fosamax))
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02202668
Study Brief:
Protocol Section:
NCT02202668