Study Results
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Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2020-12-18
2026-07-31
Brief Summary
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A Study on Predictive Model for New-onset Diabetic Foot in Type 2 Diabetes Patients.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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group ND
control group without DM non-intervention
No interventions assigned to this group
group VD
very low-risk group: diabetic patient with no loss of protective sensation(LOPS) and no peripheral artery disease(PAD).
non-intervention
No interventions assigned to this group
group LD
low-risk group: diabetic patient with LOPS or PAD non-intervention
No interventions assigned to this group
group MD
moderate-risk group: diabetic patient with LOPS + PAD non-intervention
No interventions assigned to this group
group HD
high-risk group: diabetic patient with LOPS or PAD, and one or more of the following:
* history of a foot ulcer
* a lower-extremity amputation (minor or major)
* end-stage renal disease
non-intervention
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
(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 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 post-traumatic foot osteomyelitis, fractures, car accidents and so on.
3. Age ≥18 years, the patient and (or) his family members know and agree to participate in this study.
Exclusion Criteria
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18 Years
80 Years
ALL
Yes
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Nanfang Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Qi C, Luo X, Huang J, Kong D, Zhang Y, Zou M, Zhou H. Prevalence of S. aureus and/or MRSA in hospitalized patients with diabetic foot and establishment of LAMP methods for rapid detection of the SCCmec gene. BMC Microbiol. 2024 Jan 26;24(1):36. doi: 10.1186/s12866-024-03196-6.
Zhang S, Li S, Huang J, Ding X, Qiu Y, Luo X, Meng J, Hu Y, Zhou H, Fan H, Cao Y, Gao F, Xue Y, Zou M. Gram-Negative Bacteria and Lipopolysaccharides as Risk Factors for the Occurrence of Diabetic Foot. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2604-2614. doi: 10.1210/clinem/dgad178.
Other Identifiers
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NFEC-2020-306
Identifier Type: -
Identifier Source: org_study_id
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