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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT04255004
Eligibility Criteria:
Inclusion Criteria:
* ulcers with inadequate perfusion, as indicated by a transcutaneous oxygen pressure value (TcpO2) \<30 mmHg;
* ulcers with grade I or II or III and stage C as defined by the Texas University Classification System or W1,2,3 - I 3 - FI 0,1 as defined by the WiFI Classification System
* not eligible for angioplasty or vascular surgery or following failed revascularization;
* possibility to save foot support.
Exclusion Criteria:
* lesion site above the tibial-tarsal joint;
* moderate or severe infection according by the WiFI classification system;
* NYHA class IV; d) Anemia (Hb\<8g/dl);
* coagulation disorder/thrombocytopenia (PLT\< 50,000 per microliter);
* active cancer/leukemia or lymphoma hematological disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04255004
Study Brief:
Protocol Section:
NCT04255004