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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT06227520
Eligibility Criteria:
Inclusion Criteria:
A subject will be considered eligible to participate in this study if each of the following inclusion criteria is satisfied:
1. Patient's ulcer has been present for a minimum of 2 weeks as of Day 0.
2. Study ulcer has healed \<30% in size during the 2 weeks prior to Day 0.
3. Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study.
4. Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule.
5. Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0.
6. Patient has adequate circulation to the foot as evidenced by toe pressure measurement.
7. Female patients are not pregnant at time of, or during study.
8. Patient and caregiver ready and willing to participate and comply with follow-up regime.
9. Patient or legal representative has read and signed the Institutional Ethics Review Board approved informed consent form.
Exclusion Criteria:
A subject will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied:
1. Evidence of gangrene on affected foot.
2. Ulcer is over Charcot deformity (fractures or dislocation).
3. Ulcer is non-diabetic in etiology.
4. Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic agents, or is anticipated to require such agents during study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06227520
Study Brief:
Protocol Section:
NCT06227520