Comparing Allogeneic Versus Autologous Platelet-Rich Plasma for Diabetic Wound Healing in Patients With Renal Dysfunction：a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- the wound healing rate at 4 weeks
研究概览
简要总结
Diabetic wounds are difficult to heal. Autologous platelets in diabetic patients with renal insufficiency have poor function. Allogeneic platelet plasma has a promising application prospect. Comparing the efficacy and safety differences between allogeneic platelet plasma and autologous platelet plasma is of significant importance and value for the clinical application.
详细描述
This study is a single-center, randomized, parallel control, superior trial. Fifty-six renal dysfunction patients with diabetic-related wound after wound bed preparation will be randomly assigned to the autologous platelet plasma group and allogeneic platelet plasma group in a 1:1 ratio. The primary outcome is the wound healing rate at 4 weeks (Stitches removal). The secondary outcomes include the wound healing rates at 3 weeks, the reduction rate of wound area at 2-, 3- and 4- weeks, healing time, post-operative wound infection, 7-day, 2-, 3-, 4-week pain relief progression assessed by Visual Analog Scale, incidence of mortality, reoperation, and adverse events during the follow-up period.
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
- None
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%;
- •Abnormal renal function defined as:
- •Serum creatinine >106 μmol/L (men) or >97 μmol/L (women)
- •AND eGFR <90 mL/min/1.73m² (CKD-EPI) ；
- •The patient has diabetes wounds with poor healing or prolonged healing need standard wound treatment;
- •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
- •Blood glucose is out of control or not yet effectively controlled，;
- •Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
- •Active bleeding inside the wound, and routine basic treatment plans cannot be implemented；
- •Uncontrolled systemic or disseminated infections;
- •Patients with advanced malignant tumors;
- •Pregnant or lactating women；
- •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
allogeneic platelet plasma group
diabetic-related wounds after wound bed preparation are treated by the allogeneic platelet plasma
干预措施: allogeneic platelet plasma (Drug)
autologous platelet plasma group
diabetic-related wounds after wound bed preparation are treated by the autologous platelet plasma
干预措施: autologous platelet plasma (Drug)
结局指标
主要结局
the wound healing rate at 4 weeks
时间窗: by the end of 4 weeks
calculated as the percentage of healed wounds by the end of 4 weeks
次要结局
未报告次要终点
研究者
Long Zhang
Head of Wound Healing Center
Peking University Third Hospital