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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT06795620
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years old,
* Patients with CLI according international definition: 1) rest pain of ischemic origin or ischemic trophic disorder present for at least 15 days, and 2) an ankle pressure ≤50 mmHg (≤70 mmHg for diabetic patients) or a toe pressure ≤30 mmHg or a TcPO2 ≤30 mmHg,
* Patient not revascularizable by decision of the surgeon or anesthesiologist orpatient with persistent critical ischemia after revascularization,
* Patient with a life expectancy greater than 6 months,
* Patients who signed the informed consent,
* Women of childbearing age with effective contraception (oral contraception, IUD, dermal implant) and with negative pregnancy test,
* Patient affiliated to a social security system.
Exclusion Criteria:
* Need of a major amputation (amputation at or above the ankle) within 1 month following the inclusion,
* Another clinical trial participation (except observational studies),
* Patient with active cancer history in the 5 previous years except cured basal cell carcinoma or cured low-stage melanoma,
* Patient allergic to local anesthetics
* Immunosuppressive therapy
* Ulcers with exposure of tendons, osteomyelitis, or clinically uncontrolled infection,
* Patient under the protection of justice or under guardianship or curatorship.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06795620
Study Brief:
Protocol Section:
NCT06795620