Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT04916457

The Role of Skin Microecology in Diabetic Skin Lesions

Led by Nanfang Hospital, Southern Medical University · Updated on 2025-06-06

200

Participants Needed

1

Research Sites

293 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Role of Skin Microecology in Diabetic Skin Lesions

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • For observation group: diagnosed with type 2 diabetes according to WHO 1999 criteria
  • For control group: ruled out diabetes according to WHO 1999 criteria
  • Participants or their family members understand and agree to participate
  • Patients requiring surgical operations below the knee, such as debridement or amputation, in relevant hospital departments
  • Non-diabetic patients needing surgical operations below the knee due to trauma or other reasons
Not Eligible

You will not qualify if you...

  • Presence of other skin diseases
  • Use of medically prescribed soap for bathing or cosmetics on the feet
  • Severe liver or kidney disease
  • Immune system diseases
  • HIV infection
  • Malignant tumors
  • Use of immunosuppressive drugs within the last four weeks
  • Refusal to participate by patient or family
  • Judged unsuitable by researchers to participate

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nanfang Hospital

Guangzhou, Guangdong, China, 518000

Actively Recruiting

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Research Team

X

Xiaoyan Tan

CONTACT

S

Shili Zhang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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