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Not yet recruitingNCT07020559Updated Aug 26, 2025

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

A Phase 4 interventional study of allogeneic platelet plasma and autologous platelet plasma in Diabetic Wounds, Platelet Rich Plasma and Allogeneic Blood Transfusions, sponsored by Peking University Third Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-26.

Sponsored by Peking University Third Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Diabetic wounds
  • Platelet Rich Plasma
  • allogeneic blood
  • renal dysfunction
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 56 is above the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Active comparator
    autologous platelet plasma group

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

    Drug: autologous platelet plasma

  • Experimental
    allogeneic platelet plasma group

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

    Drug: allogeneic platelet plasma

Interventions

  • Drugallogeneic platelet plasma

    Al-PRP derived from healthy blood donors

  • Drugautologous platelet plasma

    Autologous platelet-rich plasma from the patient themselves

06

What researchers measure

Primary outcomes

  1. the wound healing rate at 4 weeks

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

    Time frame: by the end of 4 weeks

07

Study locations

1 site
  • Peking University Third Hospital
    Beijing, Beijing Municipality 100191, China
    • Yunfeng Li, Medical Doctor · Contact · liyunfeng1106@163.com
    • Yunfeng Li, Medical Doctor · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07020559
Lead sponsor
Peking University Third Hospital
Responsible party
Long Zhang (Head of Wound Healing Center, Peking University Third Hospital) — Principal investigator
First posted
Jun 13, 2025
Start date
Apr 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
May 2028 (estimated)
Last update
Aug 26, 2025

Study contacts

Long Zhang Executive Deputy Director, Medical Doctor
Contact
liyunfeng1106@163.com
+86 010-82266699

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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