Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Related Wound：a Randomized Controlled Trial

Peking University

Status: Completed

Conditions: Diabetic Foot

Treatments: Device: Platelet Rich Plasma; Device: Platelet Fibrin Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT05979584

Long2023-DFU-PFP

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups, including a placebo group

Platelet Fibrin Plasma

Experimental group

Description:

Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.

Treatment:

Device: Platelet Fibrin Plasma

Platelet Rich Plasma

Placebo Comparator group

Description:

Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.

Treatment:

Device: Platelet Rich Plasma