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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT06515093
Eligibility Criteria:
Inclusion Criteria:
1. Subject is at least 18 years of age
2. Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes
3. Subject's wound is located on foot or ankle (DFU) or leg (VLU)
4. Subject has diabetic foot ulcer \> 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer \> 1.0 cm2 and ≤ 50 cm2
5. Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mm Hg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great Toe Pressure ≥ 50 mmHg
6. Subject is willing and able to comply with all protocol requirements
7. Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
Exclusion Criteria:
1. Subject is pregnant
2. Subject with diagnosed diabetes has HbA1C \> 12 within 3 months Prior to randomization
3. Subject has \> 30% reduction in wound size after 2-week run-in period
4. Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria
5. Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI
6. Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. Chronic oral steroid use is not excluded if dose \< 10 mg per day of prednisone
7. Subject is currently undergoing cancer treatment
8. Subject has used biologic skin substitutes within 14 days of enrollment
9. Subject has an allergy to suture material
10. Subject has life expectancy less than six-months as assessed by the investigator
11. Subject is participating in another clinical research study prior to this study completion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06515093
Study Brief:
Protocol Section:
NCT06515093