Clinical trial Recruiting at 1 site Observational Ages 18 to 80

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.

More Diabetic Foot trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment200 (estimated)
SponsorNanfang Hospital, Southern Medical University
Academic / other
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedDecember 18, 2020
Main results expectedJuly 31, 2026
Study endsJuly 31, 2026
Registry record updatedJune 6, 2025
Trial IDNCT04916457 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.