Status:
COMPLETED
Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Related Wound：a Randomized Controlled Trial
Lead Sponsor:
Peking University Third Hospital
Conditions:
Diabetic Foot
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ans...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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.
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2025
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT05979584
Start Date
November 20 2023
End Date
March 9 2025
Last Update
March 17 2025
Active Locations (1)
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1
Peking University 3rd Hospital
Beijing, Beijing Municipality, China, 010