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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
allogeneic platelet plasma
DrugAl-PRP derived from healthy blood donors
autologous platelet plasma
DrugAutologous platelet-rich plasma from the patient themselves
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: autologous platelet plasma groupActive comparator 1 intervention
Group B: allogeneic platelet plasma groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the wound healing rate at 4 weeks
calculated as the percentage of healed wounds by the end of 4 weeks
Time frame
by the end of 4 weeksSponsors and contacts
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Source ClinicalTrials.gov
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