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

NCT05979584 | Completed DMC

• 1 other identifier: Long2023-DFU-PFP
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

Diabetes foot ulcer; Platelet Rich Plasma; Platelet Fibrin Plasma

Outcome Measures

Primary Outcomes (1)

• 4-week wound healing rate

  By D28, the proportion of healed wounds in the total number of cases

  4-week

Secondary Outcomes (6)

• The 4-week wound area reduction rate

  4-week

• The 8-week wound healing rate

  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

  during the follow-up period

Study Arms (2)

Platelet Fibrin Plasma

EXPERIMENTAL

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

Platelet Rich Plasma

PLACEBO COMPARATOR

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

Interventions

Platelet Fibrin Plasma DEVICE

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

Platelet Fibrin Plasma

Platelet Rich Plasma DEVICE

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

Platelet Rich Plasma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University 3rd Hospital

Beijing, Beijing Municipality, 010, China

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 7, 2023
• Study Start: November 20, 2023
• Primary Completion: March 4, 2025
• Study Completion: March 9, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)