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

NCT ID: NCT07020559

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2028-05-31

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 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.

Conditions

Diabetic Wounds; Platelet Rich Plasma; Allogeneic Blood Transfusions; Renal Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

autologous platelet plasma group

diabetic-related wounds after wound bed preparation are treated by the autologous platelet plasma

Group Type: ACTIVE_COMPARATOR

autologous platelet plasma

Intervention Type: DRUG

Autologous platelet-rich plasma from the patient themselves

allogeneic platelet plasma group

diabetic-related wounds after wound bed preparation are treated by the allogeneic platelet plasma

Group Type: EXPERIMENTAL

allogeneic platelet plasma

Intervention Type: DRUG

Al-PRP derived from healthy blood donors

Interventions

allogeneic platelet plasma

Al-PRP derived from healthy blood donors

Intervention Type: DRUG

autologous platelet plasma

Autologous platelet-rich plasma from the patient themselves

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Long Zhang

Head of Wound Healing Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Long Zhang Executive Deputy Director, Medical Doctor

Role: CONTACT

liyunfeng1106@163.com

+86 010-82266699

Facility Contacts

Yunfeng Li, Medical Doctor

Role: primary

liyunfeng1106@163.com

Other Identifiers

Long2025-DW-alPRP

Identifier Type: -

Identifier Source: org_study_id