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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05979584
• Other study ID #: Long2023-DFU-PFP
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: December 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: August 31, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

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

Locations

Country	Name	City	State
China	Peking University 3rd Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4-week wound healing rate	By D28, the proportion of healed wounds in the total number of cases	4-week
Secondary	The 4-week wound area reduction rate	(pre-treatment wound area - post-treatment wound area)/pre-treatment wound area × 100%	4-week
Secondary	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
Secondary	Total blood volume required to prepare platelet plasma		day 0
Secondary	Extracted platelet plasma volume		day 0
Secondary	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
Secondary	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