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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Xiaoyan Tan
- 電話番号：02062786842
- メール：nfyykyc@163.com
研究連絡先のバックアップ
- 名前：Shili Zhang
- 電話番号：+86-17817182600
- メール：sallyz11@163.com
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、518000
- 募集
- Nanfang Hospital
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コンタクト：
- Xiaoyan Tan
- 電話番号：02061641036
- メール：nfyykyc@163.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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group ND
control group without DM non-intervention
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group VD
very low-risk group: diabetic patient with no loss of protective sensation(LOPS) and no peripheral artery disease(PAD). non-intervention |
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group LD
low-risk group: diabetic patient with LOPS or PAD non-intervention
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group MD
moderate-risk group: diabetic patient with LOPS + PAD non-intervention
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group HD
high-risk group: diabetic patient with LOPS or PAD, and one or more of the following:
non-intervention |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
omics analysis of skin microbiome
時間枠：from September 2020 to July 2021
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Compared with non-diabetic patients, the differences in skin microbiome of diabetic patients with different disease progression.
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from September 2020 to July 2021
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change of skin pathology in DM
時間枠：From August 2021 to July 2024
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The pathological changes of the skin tissues of diabetic patients with different disease progression.
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From August 2021 to July 2024
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The incidence of developing into diabetic foot among the groups
時間枠：From August 2023 to July 2025
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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
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From August 2023 to July 2025
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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