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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT07020559
Eligibility Criteria:
Inclusion Criteria:
1. The patient is aged 18-80 years old;
2. Diagnosed as type 1 or type 2 diabetes according to the World Health Organization standard, blood sugar has been controlled before enrollment, and the level of Glycated hemoglobin HbA1c is less than 10%;
3. Abnormal renal function defined as:
* Serum creatinine \>106 μmol/L (men) or \>97 μmol/L (women)
* AND eGFR \<90 mL/min/1.73m² (CKD-EPI) ；
4. The patient has diabetes wounds with poor healing or prolonged healing need standard wound treatment;
5. After preparing the wound bed, the condition for using platelet plasma to close the wound is met\*;
6. Voluntarily sign an informed consent form;
Exclusion Criteria:
1. Blood glucose is out of control or not yet effectively controlled，;
2. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
3. Active bleeding inside the wound, and routine basic treatment plans cannot be implemented；
4. Uncontrolled systemic or disseminated infections;
5. Patients with advanced malignant tumors;
6. Pregnant or lactating women；
7. The patient is unable to cooperate or has mental disorders;
8. According to the judgment of the researchers, the patient has a clear and irremovable cause that affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07020559
Study Brief:
Protocol Section:
NCT07020559