Diabetic WoundsPhase 4NCT07020559
Allogeneic vs Autologous PRP for Diabetic Wounds in Renal Dysfunction: a Randomized Controlled Trial
A Phase 4 study testing allogeneic platelet plasma and autologous platelet plasma in people with Diabetic Wounds and Platelet Rich Plasma, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Wounds, Platelet Rich Plasma, Allogeneic Blood Transfusions
- What is being tested?
- allogeneic platelet plasma and autologous platelet plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yunfeng Li, Medical Doctor, liyunfeng1106@163.com
Yunfeng Li, Medical Doctor
About this study
Official title: Comparing Allogeneic Versus Autologous Platelet-Rich Plasma for Diabetic Wound Healing in Patients With Renal Dysfunction：a Randomized Controlled Trial
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.
- Being tested
- allogeneic platelet plasma, autologous platelet plasma
- Keywords
- Diabetic wounds, Platelet Rich Plasma, allogeneic blood, renal dysfunction
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic platelet plasmaDrug
Al-PRP derived from healthy blood donors
autologous platelet plasmaDrug
Autologous platelet-rich plasma from the patient themselves
| Study group | Role | What they receive |
|---|---|---|
| autologous platelet plasma group | Active comparator | diabetic-related wounds after wound bed preparation are treated by the autologous platelet plasma Receives: Drug: autologous platelet plasma |
| allogeneic platelet plasma group | Experimental | diabetic-related wounds after wound bed preparation are treated by the allogeneic platelet plasma Receives: Drug: allogeneic platelet plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
the wound healing rate at 4 weeks
calculated as the percentage of healed wounds by the end of 4 weeks
Measured: by the end of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study startApr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic WoundsStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Zhang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020559
- Sponsor's protocol ID
- Long2025-DW-alPRP
- Status last verified
- Aug 2025
- First submitted
- 6 Jun 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Allogeneic Versus Autologous Platelet-Rich Plasma for Diabetic Wound Healing in Patients With Renal Dysfunction：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07020559
- Acronym / sponsor ID
- Long2025-DW-alPRP
- Keywords
- Diabetic wounds, Platelet Rich Plasma, allogeneic blood, renal dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autologous platelet plasma group | Active comparator | Drug: autologous platelet plasmadiabetic-related wounds after wound bed preparation are treated by the autologous platelet plasma |
| allogeneic platelet plasma group | Experimental | Drug: allogeneic platelet plasmadiabetic-related wounds after wound bed preparation are treated by the allogeneic platelet plasma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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*;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic platelet plasmaAl-PRP derived from healthy blood donors | Drug | allogeneic platelet plasma group |
| autologous platelet plasmaAutologous platelet-rich plasma from the patient themselves | Drug | autologous platelet plasma group |
Primary outcome
the wound healing rate at 4 weeks
Time frame: by the end of 4 weeks
calculated as the percentage of healed wounds by the end of 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Wounds
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Diabetic Foot Ulcer
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Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing allogeneic platelet plasma and autologous platelet plasma in people with Diabetic Wounds and Platelet Rich Plasma, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Long Zhang Executive Deputy Director, Medical Doctor (+86 010-82266699, liyunfeng1106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the wound healing rate at 4 weeks (time frame: by the end of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.