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Recruiting NCT04916457

The Role of Skin Microecology in Diabetic Skin Lesions

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Trial Parameters

Condition Diabetic Foot
Sponsor Nanfang Hospital, Southern Medical University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2020-12-18
Completion 2026-07-31

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Brief Summary

This study is an observational study. Collect cotton swabs of the surface skin are obtained from the non-diabetic and diabetic patients hospitalized in the Nanfang Hospital of Southern Medical University. The investigators use omics technology to identify the structure and functions of cutaneous microbiome, analyze the characteristics of the skin flora of diabetic patients, and find the difference in skin microbiota among diabetic patients with different risk levels for developing into diabetic foot. Then, the participants will be followed up to compare the incidence of ulcers among different groups. And the skin tissues discarded during surgical operations of non-diabetic and diabetes patients are collected for pathological examination. Finally, based on the results of 16S high-throughput sequencing, metagenomics, etc., specific flora could be extracted from human skin flora cotton swabs, and animal experiments are performed to explore the effect of skin micro-ecology on diabetic skin lesions. The investigators will explore in animal experiments to regulate the influence of skin micro-ecology on diabetic skin lesions through treatment methods such as different hypoglycemic drugs and probiotic emulsions.

Eligibility Criteria

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: 1. Control subjects that was ruled out diabetes according to the WHO 1999 diagnostic criteria for euglycemia. 2. 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: 1. The patient was diagnosed with type 2 diabetes in the Endocrinology Department, Burns Department, Traumatology Orthopedics, Plastic Surgery in Nanfang hospital. 2. 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: 1. The patient without type 2 diabetes in the Endocrinology Department, Burns Department, Traumatology Ortho

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