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

Not Applicable

Recruiting

• Conditions: Diabetic Foot
• Interventions: Device: Platelet Fibrin Plasma; Device: Platelet Rich Plasma

• Registration Number: NCT05979584
• Lead Sponsor: Peking University Third Hospital

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-29
• Study First Submitted QC: 2023-07-29
• Study First Posted: 2023-08-07
• Study Start: 2023-11-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-11-15
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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;

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
4-week wound healing rate	4-week	By D28, the proportion of healed wounds in the total number of cases

Secondary Outcome Measures

Name	Time	Method
The 4-week wound area reduction rate	4-week	(pre-treatment wound area - post-treatment wound area)/pre-treatment wound area × 100%
The 8-week wound healing rate	8-week	by the end of 8 weeks, the proportion of healed wounds to the total number of cases
Total blood volume required to prepare platelet plasma	day 0
adverse events related to blood collection during the follow-up period	during the follow-up period	such as ecchymosis/hematoma/bleeding, thrombophlebitis, and unstable circulation
Extracted platelet plasma volume	day 0
Infection evaluation	during the follow-up period	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

Trial Locations

Locations (1)

Peking University 3rd Hospital; 🇨🇳 Beijing, Beijing, China