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

This study is a single-center, randomized, parallel control, superior trial. Fifty-six renal dysfunction patients with diabetic-related wound after wound bed preparation will be randomly assigned to the autologous platelet plasma group and allogeneic platelet plasma group in a 1:1 ratio. The primary outcome is the wound healing rate at 4 weeks (Stitches removal). The secondary outcomes include the wound healing rates at 3 weeks, the reduction rate of wound area at 2-, 3- and 4- weeks, healing time, post-operative wound infection, 7-day, 2-, 3-, 4-week pain relief progression assessed by Visual Analog Scale, incidence of mortality, reoperation, and adverse events during the follow-up period.

Inclusion criteria

• The patient is aged 18-80 years old;
• 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%;
• 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) ；
• The patient has diabetes wounds with poor healing or prolonged healing need standard wound treatment;
• After preparing the wound bed, the condition for using platelet plasma to close the wound is met*;
• Voluntarily sign an informed consent form;

Exclusion criteria

• Blood glucose is out of control or not yet effectively controlled，;
• Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
• Active bleeding inside the wound, and routine basic treatment plans cannot be implemented；
• Uncontrolled systemic or disseminated infections;
• Patients with advanced malignant tumors;
• Pregnant or lactating women；
• The patient is unable to cooperate or has mental disorders;
• 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.