Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Related Wound：a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 4-week wound healing rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Platelet Fibrin Plasma (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.
干预措施: Platelet Rich Plasma (Device)
结局指标
主要结局
4-week wound healing rate
时间窗: 4-week
By D28, the proportion of healed wounds in the total number of cases
次要结局
- 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)
研究者
Long Zhang
Professor
Peking University Third Hospital