NCT04916457 The Role of Skin Microecology in Diabetic Skin Lesions
| NCT ID | NCT04916457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Diabetic Foot |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-12-18 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2020-12-18 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04916457 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Diabetic Foot. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04916457 currently recruiting?
Yes, NCT04916457 is actively recruiting participants. Contact the research team at nfyykyc@163.com for enrollment information.
Where is the NCT04916457 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04916457 clinical trial?
NCT04916457 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 200 participants.