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The Role of Skin Microecology in Diabetic Skin Lesions

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ClinicalTrials.gov Identifier: NCT04916457
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Brief Summary:
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Explore the Role of Skin Microecology in Diabetic Skin Lesions Based on Multi-omics Data Analysis
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. omics analysis of skin microbiome [ Time Frame: from September 2020 to July 2021 ]
    Compared with non-diabetic patients, the differences in skin microbiome of diabetic patients with different disease progression.

  2. change of skin pathology in DM [ Time Frame: From August 2021 to July 2024 ]
    The pathological changes of the skin tissues of diabetic patients with different disease progression.

  3. The incidence of developing into diabetic foot among the groups [ Time Frame: From August 2023 to July 2025 ]
    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


Biospecimen Retention:   Samples With DNA
skin cotton sample, skin tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
200 cases, 40 cases in each group
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04916457


Contacts
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Contact: Xiaoyan Tan 02062786842 nfyykyc@163.com
Contact: Shili Zhang +86-17817182600 sallyz11@163.com

Locations
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China, Guangdong
Nanfang Hospital Recruiting
Guangzhou, Guangdong, China, 518000
Contact: Xiaoyan Tan    02061641036    nfyykyc@163.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04916457    
Other Study ID Numbers: NFEC-2020-306
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanfang Hospital of Southern Medical University:
Diabetic foot
skin micro-ecology
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies