Clinical Efficacy Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 2-week reduction rate of wound area
研究概览
简要总结
Yunnan Baiyao has been treating all kinds of wounds for 120 years, but the evidence of Evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. This study explored the possible indications and use methods of Yunnan Baiyao in different stages of Diabetic foot, and obtained Evidence-based medicine evidence of clinical efficacy. Obtain the discarded tissues of Diabetic foot patients in the treatment and control groups of Yunnan Baiyao after wound debridement, conduct Transcriptome (BulkRNA seq) analysis and detection on the wound tissues, and analyze the related signal pathways and functional genes with significant differences, to help clarify the possible treatment targets of Yunnan Baiyao.
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 age of the subjects is 18-80 years old;
- •Diagnose diabetes according to WHO standards;
- •Diagnosis of Diabetic foot;
- •Confirmed as one of the stages of infection progression and granulation growth;
- •Voluntarily participate in this study and 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;
- •Blood glucose is out of control, Glucose test#Fasting blood sugar>15mmol /L, Glycated hemoglobin>12%;
- •There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
- •Serum albumin<20g/L; Hemoglobin<60g/L; Platelets<50 × 109/L;
- •Late stage subjects with malignant tumors;
- •Active period of autoimmune diseases;
- •Have a history of allergy to Yunnan Baiyao;
- •The subject is unable to cooperate or has mental disorders;
- •According to the judgment of the researcher, the subject has a clear reason that cannot be removed and 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
ointment group 2
On the basis of the optimal clinical treatment scheme, Yunnan Baiyao ointment was used to treat the wound of granulation period patients for 2 weeks
干预措施: Yunnan Baiyao (Drug)
powder group 1
On the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder was used to treat the wound of progressive infection period patients for 2 weeks
干预措施: Yunnan Baiyao (Drug)
ointment group 1
On the basis of the optimal clinical treatment scheme, Yunnan Baiyao ointment was used to treat the wound of progressive infection period patients for 2 weeks
干预措施: Yunnan Baiyao (Drug)
powder group 2
On the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder was used to treat the wound of granulation period patients for 2 weeks
干预措施: Yunnan Baiyao (Drug)
结局指标
主要结局
2-week reduction rate of wound area
时间窗: 2 weeks
Difference in wound area before and after treatment
次要结局
未报告次要终点
研究者
Long Zhang
Professor
Peking University Third Hospital