Menu
Not yet recruiting NCT07020559

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

Phase IV Interventional Diabetic Wounds Platelet Rich Plasma Allogeneic Blood Transfusions Renal Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: allogeneic platelet plasma, autologous platelet plasma.
Who it may be relevant to
Registry conditions: Diabetic Wounds, Platelet Rich Plasma, Allogeneic Blood Transfusions, Renal Dysfunction. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparing Allogeneic Versus Autologous Platelet-Rich Plasma for Diabetic Wound Healing in Patients With Renal Dysfunction：a Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

  • Drug allogeneic platelet plasma
    Al-PRP derived from healthy blood donors
  • Drug autologous platelet plasma
    Autologous platelet-rich plasma from the patient themselves

Primary outcome measures

  • the wound healing rate at 4 weeks [Time frame: by the end of 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT07020559 · Long2025-DW-alPRP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗