The Role of Skin Microecology in Diabetic Skin Lesions

Diabetic Foot Clinical Trial

Official title: Explore the Role of Skin Microecology in Diabetic Skin Lesions Based on Multi-omics Data Analysis

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Diabetic Foot

• NCT number: NCT04916457
• Study type: Observational
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xiaoyan Tan
• Phone: 02062786842
• Email: nfyykyc@163.com
• Status: Recruiting
• Start date: December 18, 2020
• Completion date: July 31, 2025