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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT03827902
Eligibility Criteria:
Inclusion Criteria:
* Type 2 Diabetes
* 18 years and older
* A1C greater than or equal to 8.5% within the preceding 6 months
* A1C greater than 8% on day of enrollment
* Active diabetic foot ulcer or wound receiving treatment in the Foot Wound clinic at Parkland (ulcer that meets University of Texas Classification Grade 1 or 2 of any stage)
Exclusion Criteria:
* Chronic osteomyelitis (even if completed active therapy)
* Moderate/severe lower limb infection (per Infectious Diseases Society of America criteria)
* Diabetic Foot Ulcer and Wound Infection on Charcot Foot
* Any serious/unstable medical condition that interferes with treatment assignment
* Ankle Brachial Index less than 0.7 or toe pressures less than 30mmHg
* Unwilling to participate or receive injectable treatment or unable to keep appointments
* Non-English or Non-Spanish speakers
* Pregnant or planning to become pregnant
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03827902
Study Brief:
Protocol Section:
NCT03827902