Exploring the role of skin bacteria in diabetic skin conditions
Official title: Explore the Role of Skin Microecology in Diabetic Skin Lesions Based on Multi-omics Data Analysis
Run by Nanfang Hospital, Southern Medical University · NCT04916457 · Data updated 2026-11-12
This study is trying to see how the bacteria on the skin of diabetic patients differ from those without diabetes to help find ways to prevent foot problems.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | December 18, 2020 |
| Main results expected | July 31, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | June 6, 2025 |
| Trial ID | NCT04916457 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults diagnosed with type 2 diabetes and those without diabetes for comparison.
✕Probably not a fit
Patients with conditions unrelated to diabetes or those who do not require surgical intervention may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects skin swab samples from both diabetic and non-diabetic patients at Nanfang Hospital to analyze the skin microbiome's structure and function. By employing advanced omics technologies, the study aims to identify differences in skin flora among diabetic patients at varying risk levels for developing diabetic foot ulcers. Participants will be followed up to assess the incidence of ulcers, and discarded skin tissues from surgeries will be examined for pathological changes. The ultimate goal is to uncover mechanisms that could lead to early screening and prevention strategies for diabetic foot complications.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and prevention strategies for diabetic foot ulcers.
How similar studies have gone: While the specific approach of this study is novel, previous studies have shown that understanding skin microbiota can influence treatment strategies for diabetic conditions.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Nanfang Hospital
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Xiaoyan Tan
- Email: nfyykyc@163.com
- Phone: 02062786842
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Miro3D Wound Matrix for Diabetic Foot Ulcers
This study tests whether adding Miro3D Wound Matrix to standard care helps healing diabetic foot ulcers in adults.
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Topical Capsadyn (palmitated capsaicin) for diabetic neuropathic foot pain
This study will test whether a topical Capsadyn cream can reduce foot pain in adults with diabetic peripheral neuropathy.
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Single-layer placental graft plus standard care for stubborn diabetic foot ulcers
This trial will try a single-layer placental-based graft together with usual wound care for adults whose diabetic foot ulcers did not heal after standard treatment in an earlier trial.
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Using human placental membrane wraps with regular wound care to help heal stubborn diabetic foot and venous leg ulcers
This trial tests whether adding one of four human placental membrane wraps to standard wound care helps people with nonhealing diabetic foot or venous leg ulcers heal faster and more completely than standard care alone.
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Evaluating full-body imaging technology for skin disease detection
This study is testing a new full-body imaging technology to see if it can help doctors better detect and monitor skin diseases like skin cancer and eczema.
-
Non-invasive imaging to measure skin composition and structure
This study is testing a new non-invasive imaging technology to see if it can accurately measure different components and structures of skin in people visiting their primary care doctor, especially those at higher risk for heart issues or diabetes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.