allogeneic platelet plasma: Al-PRP derived from healthy blood donors
autologous platelet plasma: Autologous platelet-rich plasma from the patient themselves
Study summary
Diabetic wounds are difficult to heal. Autologous platelets in diabetic patients with renal insufficiency have poor function. Allogeneic platelet plasma has a promising application prospect. Comparing the efficacy and safety differences between allogeneic platelet plasma and autologous platelet plasma is of significant importance and value for the clinical application.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
the wound healing rate at 4 weeks — by the end of 4 weeks calculated as the percentage of healed wounds by the end of 4 weeks
Trial sites (1)
Facility
City
Region
Status
Peking University Third Hospital
Beijing
Beijing Municipality
More Peking University Third Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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