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

• ClinicalTrials.gov Identifier: NCT05979584
• Recruitment Status: Recruiting
• First Posted: August 7, 2023
• Last Update Posted: December 20, 2023
• Sponsor: Peking University Third Hospital
• Information provided by (Responsible Party): Long Zhang, Peking University Third Hospital

Tracking Information

• First Submitted Date: July 29, 2023
• First Posted Date: August 7, 2023
• Last Update Posted Date: December 20, 2023
• Actual Study Start Date: November 15, 2023
• Estimated Primary Completion Date: November 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2023)

4-week wound healing rate [ Time Frame: 4-week ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 14, 2023)

• The 4-week wound area reduction rate [ Time Frame: 4-week ]
  (pre-treatment wound area - post-treatment wound area)/pre-treatment wound area × 100%
• The 8-week wound healing rate [ Time Frame: 8-week ]
  by the end of 8 weeks, the proportion of healed wounds to the total number of cases
• Total blood volume required to prepare platelet plasma [ Time Frame: day 0 ]
• Extracted platelet plasma volume [ Time Frame: day 0 ]
• adverse events related to blood collection during the follow-up period [ Time Frame: during the follow-up period ]
  such as ecchymosis/hematoma/bleeding, thrombophlebitis, and unstable circulation
• Infection evaluation [ Time Frame: during the follow-up period ]
  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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: 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.
• 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.

Study Arms

• 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.
  Intervention: Device: Platelet Fibrin Plasma
• 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.
  Intervention: Device: Platelet Rich Plasma

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 29, 2023): 56
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2025
• Estimated Primary Completion Date: November 15, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05979584
• Other Study ID Numbers: Long2023-DFU-PFP
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Long Zhang, Peking University Third Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Peking University Third Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Peking University Third Hospital
• Verification Date: December 2023