Clinical trial NCT07020559: Allogeneic vs Autologous PRP for Diabetic Wounds in Renal Dysfunction: a Randomized Controlled Trial
Official title: Comparing Allogeneic Versus Autologous Platelet-Rich Plasma for Diabetic Wound Healing in Patients With Renal Dysfunction：a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Diabetic Wounds
Platelet Rich Plasma
Allogeneic Blood Transfusions
Renal Dysfunction
Keywords: Diabetic wounds
Platelet Rich Plasma
allogeneic blood
renal dysfunction
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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, 6, and 8 weeks, healing time, post-operative wound infection, 7-day, 2-, 3-, 4-, 6-, 8-week pain relief progression assessed by Visual Analog Scale, incidence of mortality, reoperation, and adverse events during the follow-up period.

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.

Primary outcomes:
measure: the wound healing rate at 4 weeks
timeFrame: by the end of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: