Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Related Wound：a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Platelet Fibrin Plasma
- Conditions
- Diabetic Foot
- Sponsor
- Peking University Third Hospital
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- 4-week wound healing rate
- Status
- Completed
- Last Updated
- 15 days ago
Overview
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.
Investigators
Long Zhang
Professor
Peking University Third Hospital
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
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: Platelet Fibrin Plasma
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: Platelet Rich Plasma
Outcomes
Primary Outcomes
4-week wound healing rate
Time Frame: 4-week
By D28, the proportion of healed wounds in the total number of cases
Secondary Outcomes
- 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)
- adverse events related to blood collection during the follow-up period(during the follow-up period)
- Extracted platelet plasma volume(day 0)
- Infection evaluation(during the follow-up period)