The Role of Skin Microecology in Diabetic Skin Lesions
Explore the Role of Skin Microecology in Diabetic Skin Lesions Based on Multi-omics Data Analysis
研究概览
地位
详细说明
The study intends to explore the mechanism of diabetic skin micro-ecology in diabetic skin diseases, and find new ways of early screening and prevention for diabetic foot.
This study is a prospective observational study. Adult participants were divided into the following 5 groups (n=200, 40 in each group): control group, very low-risk group, low-risk group, moderate-risk group, and high-risk group. Sterile rayon tipped swabs were pre-moistened with a sterile solution containing 0.15 M NaCl and 0.1% Tween 20. All swabs samples were collected from the intact skin at plantar anterior. And the skin cotton swab was subjected to 16s rDNA high-throughput sequencing, metagenomic sequencing methods, etc. Based on the result, the investigators will analyse the change of the cutaneous microbiome in DM as the disease condition progresses.
The skin tissues of the control group and observation group who met the inclusion criteria were also collected during surgical operations, and pathological and immunohistochemistry tests were performed respectively to analyze the pathological changes of diabetic skin tissues in different disease progressions.
According to the results of multi-omics analysis, the research team screen for the specific flora. Then sort out and culture specific strains, and establish mouse model of microbiota transplantation in order to explore the effects of regulating skin microecology on diabetic skin lesions through different treatment methods such as hypoglycemic drugs and probiotic emulsions.
Researchers will conduct telephone follow-ups of diabetic patients, collect data, and statistically analyze the impact of changes in the skin microecology of diabetic patients on the occurrence of diabetic foot ulcers.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Xiaoyan Tan
- 电话号码：02062786842
- 邮箱：nfyykyc@163.com
研究联系人备份
- 姓名：Shili Zhang
- 电话号码：+86-17817182600
- 邮箱：sallyz11@163.com
学习地点
-
-
Guangdong
-
Guangzhou、Guangdong、中国、518000
- 招聘中
- Nanfang Hospital
-
接触：
- Xiaoyan Tan
- 电话号码：02061641036
- 邮箱：nfyykyc@163.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
1. Surface skin cotton swab collection
(1) Observation group: In the endocrinology department of Nanfang hospital, the patient were diagnosed with type 2 diabetes to the WHO 1999 diagnostic criteria for diabetes.
(2) Control group:
- Control subjects that was ruled out diabetes according to the WHO 1999 diagnostic criteria for euglycemia.
- Age ≥18 years, the patient and (or) his family members know and agree to participate in this study.
2. Skin tissue collection
(1) Observation group:
- The patient was diagnosed with type 2 diabetes in the Endocrinology Department, Burns Department, Traumatology Orthopedics, Plastic Surgery in Nanfang hospital.
- Patients who need surgical operations such as debridement and amputation below the knee joint due to various reasons such as diabetic foot osteomyelitis, fractures, car accidents and so on.
(2) Control group:
- The patient without type 2 diabetes in the Endocrinology Department, Burns Department, Traumatology Orthopedics, Plastic Surgery in Nanfang hospital.
- Patients who need surgical operations such as debridement and amputation below the knee joint due to various reasons such as post-traumatic foot osteomyelitis, fractures, car accidents and so on.
- Age ≥18 years, the patient and (or) his family members know and agree to participate in this study.
Exclusion Criteria:
The patients Including other skin diseases, using medically prescribed soap for bathing, using cosmetics on the feet, suffering from severe liver and kidney disease, immune system disease, HIV infection, malignant tumors, or using immunosuppressive drugs within the first four weeks. The patient or (and) their family members refused to participate in this study.
The researchers judged that they are not suitable to participate in this research.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
group ND
control group without DM non-intervention
|
|
group VD
very low-risk group: diabetic patient with no loss of protective sensation(LOPS) and no peripheral artery disease(PAD). non-intervention |
|
group LD
low-risk group: diabetic patient with LOPS or PAD non-intervention
|
|
group MD
moderate-risk group: diabetic patient with LOPS + PAD non-intervention
|
|
group HD
high-risk group: diabetic patient with LOPS or PAD, and one or more of the following:
non-intervention |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
omics analysis of skin microbiome
大体时间：from September 2020 to July 2021
|
Compared with non-diabetic patients, the differences in skin microbiome of diabetic patients with different disease progression.
|
from September 2020 to July 2021
|
|
change of skin pathology in DM
大体时间：From August 2021 to July 2024
|
The pathological changes of the skin tissues of diabetic patients with different disease progression.
|
From August 2021 to July 2024
|
|
The incidence of developing into diabetic foot among the groups
大体时间：From August 2023 to July 2025
|
Follow-up for 2 years to assess the impact of changes in the skin microecology of diabetic patients on the occurrence of diabetic foot ulcers
|
From August 2023 to July 2025
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.