Allogeneic vs Autologous PRP for Diabetic Wounds in Renal Dysfunction: a Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital
About this trial
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 criteria
Qualifiers
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%;
Serum creatinine >106 μmol/L (men) or >97 μmol/L (women)
AND eGFR <90 mL/min/1.73m² (CKD-EPI) ；
Disqualifiers
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;
Trial design
Treatments tested in this trial
- allogeneic platelet plasma
- autologous platelet plasma
Treatment groups
56 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov