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

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

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 Related Wound：a Randomized Controlled Trial
Actual Study Start Date : November 15, 2023
Estimated Primary Completion Date : November 15, 2024
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 4-week wound healing rate [ Time Frame: 4-week ]
    By D28, the proportion of healed wounds in the total number of cases


Secondary Outcome Measures :
  1. The 4-week wound area reduction rate [ Time Frame: 4-week ]
    (pre-treatment wound area - post-treatment wound area)/pre-treatment wound area × 100%

  2. 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

  3. Total blood volume required to prepare platelet plasma [ Time Frame: day 0 ]
  4. Extracted platelet plasma volume [ Time Frame: day 0 ]
  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05979584


Locations
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China, Beijing
Peking University 3rd Hospital Recruiting
Beijing, Beijing, China, 010
Contact: Long Zhang, Dr    11 ext 11    longzh2000@126.com   
Sponsors and Collaborators
Peking University Third Hospital
More Information
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Responsible Party: Long Zhang, Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT05979584    
Other Study ID Numbers: Long2023-DFU-PFP
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: December 20, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Long Zhang, Peking University Third Hospital:
Diabetes foot ulcer
Platelet Rich Plasma
Platelet Fibrin Plasma
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies