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Blood-based gels battle diabetic foot ulcers in head-to-head trial

NCT ID NCT05979584

Disease control Sponsor: Peking University Third Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two treatments made from patients' own blood—platelet-rich plasma and platelet-fibrin plasma—to see which works better for healing diabetic foot ulcers. 56 adults with diabetes and slow-healing foot wounds were randomly assigned to receive one of the treatments plus standard care. The main goal was to compare how many wounds healed within 4 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

56 people

The number who actually took part.

Started

Nov 2023

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. diabetes wounds with poor healing or prolonged healing need standard wound treatment; 4. There is no disseminated infection or the disseminated infection has been controlled; 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: 1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet; 2. Severe ischemia of the wound surface, unable to seek medical attention or not yet corrected; 3. Uncontrolled systemic or disseminated infections; 4. Blood glucose is out of control or not yet effectively controlled; 5. Blood system diseases with uncorrected coagulation dysfunction or platelet dysfunction; 6. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented; 7. Platelets ≤ 80 × 10\^9, hemoglobin\<90g/L; 8. Patients with advanced malignant tumors; 9. Active period of autoimmune diseases; 10. The patient is unable to cooperate or has mental disorders; 11. 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.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot

Contacts and locations

Locations

  • Peking University 3rd Hospital

    Beijing, Beijing Municipality, 010, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.