Allogeneic vs Autologous PRP for Diabetic Wounds in Renal Dysfunction: a Randomized Controlled Trial

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of two types of platelet-rich plasma (PRP) treatments for healing diabetic wounds in patients with kidney problems. One type is made from the patient's own blood (autologous), while the other comes from donated blood (allogeneic). Since diabetic wounds can be very challenging to heal, especially in people with kidney issues, this study aims to find out which treatment works better and is safer.

To be eligible for this trial, participants need to be between 18 and 80 years old, have either type 1 or type 2 diabetes with controlled blood sugar levels, and show signs of kidney dysfunction. They should also have wounds that are not healing well despite standard care. Those who join the study will receive one of the PRP treatments and will be monitored for their healing progress. It’s important to know that individuals with certain severe health conditions or infections, as well as pregnant or breastfeeding women, will not be included in the trial. This study is not yet recruiting participants, but it represents an important step toward finding better treatments for difficult-to-heal wounds in diabetic patients with kidney challenges.

Gender

ALL

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.