The Role of Skin Microecology in Diabetic Skin Lesions

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot; Diabetic Dermopathy

Detailed Description

The study intends to explore the mechanism of diabetic skin micro-ecology in diabetic skin diseases, and find new ways of early screening and prevention for diabetic foot.

This study is a prospective observational study. Adult participants were divided into the following 5 groups (n=200, 40 in each group): control group, very low-risk group, low-risk group, moderate-risk group, and high-risk group. Sterile rayon tipped swabs were pre-moistened with a sterile solution containing 0.15 M NaCl and 0.1% Tween 20. All swabs samples were collected from the intact skin at plantar anterior. And the skin cotton swab was subjected to 16s rDNA high-throughput sequencing, metagenomic sequencing methods, etc. Based on the result, the investigators will analyse the change of the cutaneous microbiome in DM as the disease condition progresses.

The skin tissues of the control group and observation group who met the inclusion criteria were also collected during surgical operations, and pathological and immunohistochemistry tests were performed respectively to analyze the pathological changes of diabetic skin tissues in different disease progressions.

According to the results of multi-omics analysis, the research team screen for the specific flora. Then sort out and culture specific strains, and establish mouse model of microbiota transplantation in order to explore the effects of regulating skin microecology on diabetic skin lesions through different treatment methods such as hypoglycemic drugs and probiotic emulsions.

Researchers will conduct telephone follow-ups of diabetic patients, collect data, and statistically analyze the impact of changes in the skin microecology of diabetic patients on the occurrence of diabetic foot ulcers.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Xiaoyan Tan; Phone Number: 02062786842; Email: nfyykyc@163.com
• Study Contact Backup: Name: Shili Zhang; Phone Number: +86-17817182600; Email: sallyz11@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 518000
      • Recruiting
      • Nanfang Hospital
      • Contact: Xiaoyan Tan; Phone Number: 02061641036; Email: nfyykyc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200 cases, 40 cases in each group

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
group ND; control group without DM non-intervention
group VD; very low-risk group: diabetic patient with no loss of protective sensation(LOPS) and no peripheral artery disease(PAD). non-intervention
group LD; low-risk group: diabetic patient with LOPS or PAD non-intervention
group MD; moderate-risk group: diabetic patient with LOPS + PAD non-intervention
group HD; high-risk group: diabetic patient with LOPS or PAD, and one or more of the following: history of a foot ulcer; a lower-extremity amputation (minor or major); end-stage renal disease non-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
omics analysis of skin microbiome	Compared with non-diabetic patients, the differences in skin microbiome of diabetic patients with different disease progression.	from September 2020 to July 2021
change of skin pathology in DM	The pathological changes of the skin tissues of diabetic patients with different disease progression.	From August 2021 to July 2024
The incidence of developing into diabetic foot among the groups	Follow-up for 2 years to assess the impact of changes in the skin microecology of diabetic patients on the occurrence of diabetic foot ulcers	From August 2023 to July 2025

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Diabetic foot; skin micro-ecology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: NFEC-2020-306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No