The Role of Skin Microecology in Diabetic Skin Lesions
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|ClinicalTrials.gov Identifier: NCT04916457|
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : August 17, 2021
|Condition or disease|
|Diabetic Foot Diabetic Dermopathy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Explore the Role of Skin Microecology in Diabetic Skin Lesions Based on Multi-omics Data Analysis|
|Actual Study Start Date :||December 18, 2020|
|Estimated Primary Completion Date :||July 31, 2024|
|Estimated Study Completion Date :||July 31, 2025|
control group without DM non-intervention
very low-risk group: diabetic patient with no loss of protective sensation(LOPS) and no peripheral artery disease(PAD).
low-risk group: diabetic patient with LOPS or PAD non-intervention
moderate-risk group: diabetic patient with LOPS + PAD non-intervention
high-risk group: diabetic patient with LOPS or PAD, and one or more of the following:
- omics analysis of skin microbiome [ Time Frame: from September 2020 to July 2021 ]Compared with non-diabetic patients, the differences in skin microbiome of diabetic patients with different disease progression.
- change of skin pathology in DM [ Time Frame: From August 2021 to July 2024 ]The pathological changes of the skin tissues of diabetic patients with different disease progression.
- The incidence of developing into diabetic foot among the groups [ Time Frame: 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04916457
|Contact: Xiaoyan Tanfirstname.lastname@example.org|
|Contact: Shili Zhangemail@example.com|
|Guangzhou, Guangdong, China, 518000|
|Contact: Xiaoyan Tan 02061641036 firstname.lastname@example.org|