NCT07020559

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	allogeneic platelet plasma	Al-PRP derived from healthy blood donors
DRUG	autologous platelet plasma	Autologous platelet-rich plasma from the patient themselves

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2028-05-01
• First posted: 2025-06-13
• Last updated: 2025-08-26

Locations

1 site across 1 country: China