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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetic Foot

Intervention / Treatment
-----------------
* Device: Platelet Fibrin Plasma
* Device: Platelet Rich Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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; Exclusion Criteria: 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; 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Fibrin Plasma<br>Participants 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<br>* Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.<br>|
| Placebo Comparator: Platelet Rich Plasma<br>Participants 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<br>* Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-week wound healing rate | By D28, the proportion of healed wounds in the total number of cases | 4-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 4-week wound area reduction rate | (pre-treatment wound area - post-treatment wound area)/pre-treatment wound area × 100% | 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 | 8-week | 
| Total blood volume required to prepare platelet plasma |  | day 0 | 
| Extracted platelet plasma volume |  | day 0 | 
| adverse events related to blood collection during the follow-up period | such as ecchymosis/hematoma/bleeding, thrombophlebitis, and unstable circulation | 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 | during the follow-up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes foot ulcer, Platelet Rich Plasma, Platelet Fibrin Plasma