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

NCT07020559 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Long2025-DW-alPRP
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Diabetic wounds; Platelet Rich Plasma; allogeneic blood; renal dysfunction

Outcome Measures

Primary Outcomes (1)

• the wound healing rate at 4 weeks

  calculated as the percentage of healed wounds by the end of 4 weeks

  by the end of 4 weeks

Study Arms (2)

autologous platelet plasma group

ACTIVE COMPARATOR

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

Drug: autologous platelet plasma

allogeneic platelet plasma group

EXPERIMENTAL

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

Drug: allogeneic platelet plasma

Interventions

allogeneic platelet plasma DRUG

Al-PRP derived from healthy blood donors

allogeneic platelet plasma group

autologous platelet plasma DRUG

Autologous platelet-rich plasma from the patient themselves

autologous platelet plasma group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Long Zhang Executive Deputy Director, Medical Doctor

CONTACT

+86 010-82266699; liyunfeng1106@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Wound Healing Center

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 13, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

CN (1)