Exploring the role of skin bacteria in diabetic skin conditions

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

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
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04916457 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with type 2 diabetes and those without diabetes for comparison.

Not a fit: Patients with conditions unrelated to diabetes or those who do not require surgical intervention may not benefit from this study.

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 performed: While the specific approach of this study is novel, previous studies have shown that understanding skin microbiota can influence treatment strategies for diabetic conditions.

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.

Where this trial is running

Guangzhou, Guangdong

• Nanfang Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xiaoyan Tan

Conditions Diabetic Foot; Diabetic Dermopathy; Diabetic foot; skin micro-ecology