Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Foot Ulcer：a Randomized Controlled Trial

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05979584
• Collaborator: (none)
• Enrollment: 56
• Arms: 2
• Anticipated Duration (Months): 17

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot	Device: Platelet Fibrin Plasma; Device: Platelet Rich Plasma	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Foot Ulcer：a Randomized Controlled Trial
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 4-week wound healing rate [4-week]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Long Zhang, Professor, Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT05979584
• Other Study ID Numbers: Long2023-DFU-PFP
• First Posted: Aug 7, 2023
• Last Update Posted: Aug 7, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Long Zhang, Professor, Peking University Third Hospital: Diabetes foot ulcer; Platelet Rich Plasma; Platelet Fibrin Plasma
• Additional relevant MeSH terms: Diabetic Foot; Foot Ulcer

Study Results

No Results Posted as of Aug 7, 2023