Diabetic FootNCT05979584
Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Related Wound：a Randomized Controlled Trial
A study testing Platelet Fibrin Plasma and Platelet Rich Plasma in people with Diabetic Foot, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this randomized control trial is to compare the efficacy and safety of Platelet Rich Plasma VS Platelet Fibrin Plasma in patients with diabetes foot ulcer. The main question it aims to answer are: Whether the Platelet Fibrin Plasma have noninferior efficacy than Platelet Rich Plasma in treatment of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Platelet Fibrin Plasma and Platelet Rich Plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to 9 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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%;
- diabetes wounds with poor healing or prolonged healing need standard wound treatment;
- There is no disseminated infection or the disseminated infection has been controlled;
- 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
- Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
- Severe ischemia of the wound surface, unable to seek medical attention or not yet corrected;
- Uncontrolled systemic or disseminated infections;
- Blood glucose is out of control or not yet effectively controlled;
- Blood system diseases with uncorrected coagulation dysfunction or platelet dysfunction;
- There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
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- Platelets ≤ 80 × 10^9, hemoglobin<90g/L;
- Patients with advanced malignant tumors;
- Active period of autoimmune diseases;
- 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.
About this study
The goal of this randomized control trial is to compare the efficacy and safety of Platelet Rich Plasma VS Platelet Fibrin Plasma in patients with diabetes foot ulcer. The main question it aims to answer are:
- Whether the Platelet Fibrin Plasma have noninferior efficacy than Platelet Rich Plasma in treatment of diabetes foot ulcer？
- Whether the Platelet Fibrin Plasma have noninferior safety than Platelet Rich Plasma in treatment of diabetes foot ulcer？ Participants will be assigned with a 1:1 ratio into intervention group and control group.
Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
- Conditions
- Diabetic Foot
- Being tested
- Platelet Fibrin Plasma, Platelet Rich Plasma
- Keywords
- Diabetes foot ulcer, Platelet Rich Plasma, Platelet Fibrin Plasma
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Fibrin PlasmaDevice
Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
Platelet Rich PlasmaDevice
Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Fibrin Plasma | Experimental | Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. Receives: Device: Platelet Fibrin Plasma |
| Platelet Rich Plasma | Placebo comparator | Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. Receives: Device: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-week wound healing rate
By D28, the proportion of healed wounds in the total number of cases
Measured: 4-week
Secondary outcomes (6)
The 4-week wound area reduction rate
(pre-treatment wound area - post-treatment wound area)/pre-treatment wound area × 100%
Measured: 4-week
The 8-week wound healing rate
by the end of 8 weeks, the proportion of healed wounds to the total number of cases
Measured: 8-week
Total blood volume required to prepare platelet plasma
Measured: day 0
Extracted platelet plasma volume
Measured: day 0
adverse events related to blood collection during the follow-up period
such as ecchymosis/hematoma/bleeding, thrombophlebitis, and unstable circulation
Measured: during the follow-up period
Infection evaluation
0 points for no infection and 1 point for local infection reduction, 2 points for local infection maintenance or aggravation, and 3 points for disseminated infections
Measured: during the follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start20 Nov 2023
- Primary completion4 Mar 2025
- Study completion9 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
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
- NCT05979584
- Sponsor's protocol ID
- Long2023-DFU-PFP
- Status last verified
- Apr 2026
- First submitted
- 29 Jul 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Related Wound：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05979584
- Acronym / sponsor ID
- Long2023-DFU-PFP
- Conditions
- Diabetic Foot
- Keywords
- Diabetes foot ulcer, Platelet Rich Plasma, Platelet Fibrin Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 9 Mar 2025 (actual)
- First posted
- 7 Aug 2023 (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.
The goal of this randomized control trial is to compare the efficacy and safety of Platelet Rich Plasma VS Platelet Fibrin Plasma in patients with diabetes foot ulcer. The main question it aims to answer are:
- Whether the Platelet Fibrin Plasma have noninferior efficacy than Platelet Rich Plasma in treatment of diabetes foot ulcer？
- Whether the Platelet Fibrin Plasma have noninferior safety than Platelet Rich Plasma in treatment of diabetes foot ulcer？ Participants will be assigned with a 1:1 ratio into intervention group and control group.
Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Fibrin Plasma | Experimental | Device: Platelet Fibrin PlasmaParticipants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. |
| Platelet Rich Plasma | Placebo comparator | Device: Platelet Rich PlasmaParticipants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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%;
- diabetes wounds with poor healing or prolonged healing need standard wound treatment;
- There is no disseminated infection or the disseminated infection has been controlled;
- After preparing the wound bed, the condition for using platelet plasma to close the wound is met;
Key exclusion criteria (11 listed)
- Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
- Severe ischemia of the wound surface, unable to seek medical attention or not yet corrected;
- Uncontrolled systemic or disseminated infections;
- Blood glucose is out of control or not yet effectively controlled;
- Blood system diseases with uncorrected coagulation dysfunction or platelet dysfunction;
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 |
|---|---|---|
| Platelet Fibrin PlasmaParticipants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. | Device | Platelet Fibrin Plasma |
| Platelet Rich PlasmaParticipants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. | Device | Platelet Rich Plasma |
Primary outcome
4-week wound healing rate
Time frame: 4-week
By D28, the proportion of healed wounds in the total number of cases
6 secondary outcomes
The 4-week wound area reduction rate
Time frame: 4-week
The 8-week wound healing rate
Time frame: 8-week
Total blood volume required to prepare platelet plasma
Time frame: day 0
Extracted platelet plasma volume
Time frame: day 0
adverse events related to blood collection during the follow-up period
Time frame: during the follow-up period
Infection evaluation
Time frame: during the follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Fibrin Plasma and Platelet Rich Plasma in people with Diabetic Foot, 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 17 Apr 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-week wound healing rate (time frame: 4-week). 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 17 Apr 2026.