Diabetic FootNCT04916457
The Role of Skin Microecology in Diabetic Skin Lesions
An observational study of Diabetic Foot and Diabetic Dermopathy, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Diabetic Dermopathy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2020to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 cases, 40 cases in each group
Who may be able to join
- 1. Surface skin cotton swab collection
- 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.
- Control group:
- Control subjects that was ruled out diabetes according to the WHO 1999 diagnostic criteria for euglycemia.
- Age ≥18 years, the patient and (or) his family members know and agree to participate in this study.
- 2. Skin tissue collection
Show all 13Show fewer
- Observation group:
- The patient was diagnosed with type 2 diabetes in the Endocrinology Department, Burns Department, Traumatology Orthopedics, Plastic Surgery in Nanfang hospital.
- 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.
- Control group:
- The patient without type 2 diabetes in the Endocrinology Department, Burns Department, Traumatology Orthopedics, Plastic Surgery in Nanfang hospital.
- 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.
- Age ≥18 years, the patient and (or) his family members know and agree to participate in this study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 518000
Xiaoyan Tan, 02061641036, nfyykyc@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot, Diabetic Dermopathy
- Keywords
- Diabetic foot, skin micro-ecology
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
omics analysis of skin microbiome
Compared with non-diabetic patients, the differences in skin microbiome of diabetic patients with different disease progression.
Measured: 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.
Measured: 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
Measured: From August 2023 to July 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start18 Dec 2020
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916457
- Sponsor's protocol ID
- NFEC-2020-306
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2021
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qi C, Luo X, Huang J, Kong D, Zhang Y, Zou M, Zhou H. Prevalence of S. aureus and/or MRSA in hospitalized patients with diabetic foot and establishment of LAMP methods for rapid detection of the SCCmec gene. BMC Microbiol. 2024 Jan 26;24(1):36. doi: 10.1186/s12866-024-03196-6.
PubMed 38279164Zhang S, Li S, Huang J, Ding X, Qiu Y, Luo X, Meng J, Hu Y, Zhou H, Fan H, Cao Y, Gao F, Xue Y, Zou M. Gram-Negative Bacteria and Lipopolysaccharides as Risk Factors for the Occurrence of Diabetic Foot. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2604-2614. doi: 10.1210/clinem/dgad178.
PubMed 36974462
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Role of Skin Microecology in Diabetic Skin Lesions Based on Multi-omics Data Analysis
- ClinicalTrials.gov ID
- NCT04916457
- Acronym / sponsor ID
- NFEC-2020-306
- Conditions
- Diabetic Foot, Diabetic Dermopathy
- Keywords
- Diabetic foot, skin micro-ecology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 cases, 40 cases in each group
Key inclusion criteria (13 listed)
- 1. Surface skin cotton swab collection
- 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.
- Control group:
- Control subjects that was ruled out diabetes according to the WHO 1999 diagnostic criteria for euglycemia.
- Age ≥18 years, the patient and (or) his family members know and agree to participate in this study.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 38279164Qi C, Luo X, Huang J, Kong D, Zhang Y, Zou M, Zhou H. Prevalence of S. aureus and/or MRSA in hospitalized patients with diabetic foot and establishment of LAMP methods for rapid detection of the SCCmec gene. BMC Microbiol. 2024 Jan 26;24(1):36. doi: 10.1186/s12866-024-03196-6.
- Derived from this study: PubMed 36974462Zhang S, Li S, Huang J, Ding X, Qiu Y, Luo X, Meng J, Hu Y, Zhou H, Fan H, Cao Y, Gao F, Xue Y, Zou M. Gram-Negative Bacteria and Lipopolysaccharides as Risk Factors for the Occurrence of Diabetic Foot. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2604-2614. doi: 10.1210/clinem/dgad178.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Diabetic Dermopathy, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Tan (02062786842, nfyykyc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
omics analysis of skin microbiome (time frame: from September 2020 to July 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04916457, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.