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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot
• Intervention / Treatment: Device: Platelet Fibrin Plasma; Device: Platelet Rich Plasma

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 010
      • Peking University 3rd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	Device: 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.

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): March 4, 2025
• Study Completion (Actual): March 9, 2025

Study Registration Dates

• First Submitted: July 29, 2023
• First Submitted That Met QC Criteria: July 29, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Platelet Rich Plasma; Diabetes foot ulcer; Platelet Fibrin Plasma
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot
• Other Study ID Numbers: Long2023-DFU-PFP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No