Diabetic Foot DiseaseNCT06777810
Identification of Pathogenic Bacteria of Diabetes Foot Ulcer
An observational study of Diabetic Foot Disease and Diabetic Foot Ulcer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The objective of this study is to design and develop a gene chip for detecting pathogenic bacteria in diabetic foot infection wounds. This innovative gene chip technology enables rapid and accurate identification of pathogens at the site of infection by detecting the 16SrDNA sequence of pathogenic bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Disease, Diabetic Foot Ulcer, Diabetes
- What is being tested?
- The infected wound of the patient's foot ulcer was collected
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2025to 30 Jun 2026
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic foot infection patients
Who may be able to join
- Age ≥ 18 years old
- Gender: males and females
- Patients diagnosed with diabetic foot infection with an infected wound
- It can provide sufficient infected wound samples (≥5mm³ infected wound tissue samples or ≥100μL infected wound secretions) and can be used for detection and analysis of gene chips
- No history of antibiotic therapy prior to sampling (within 4 weeks) or known failure to respond to antibiotic therapy (failure to respond to ≥2 antibiotics)
- Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research; Understand the study procedure, participate voluntarily and be willing to complete the entire study process, and sign the informed consent
Who cannot join
- Patients with undiagnosed diabetic foot infection
- Patients who had received antibiotics within 4 weeks prior to sampling
- Complicated with serious systemic disease (e.g., malignant tumor, severe cardiopulmonary insufficiency, etc.)
- Pregnant or lactating women
- Cognitive impairment or inability to cooperate with the research process
- History of allergies or allergies to materials related to the study
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
National Clinical Medical Research Center for Metabolic Diseases (Shanghai)
Shanghai
Weiqing Wang, Professor, 008621-64370045, wqingw61@163.com
About this study
Official title: Genetic Identification and Quantitative Analysis of Pathogenic Bacteria of Diabetic Foot Ulcer Infection
The objective of this study is to design and develop a gene chip for detecting pathogenic bacteria in diabetic foot infection wounds. This innovative gene chip technology enables rapid and accurate identification of pathogens at the site of infection by detecting the 16SrDNA sequence of pathogenic bacteria.
Diabetic foot infection is a common serious complication in diabetic patients, often accompanied by complex pathogenic bacteria population, and due to the variety of infection types, traditional pathogen detection methods are time-consuming and low accuracy, patients may miss the best treatment opportunity. Now commonly used genetic identification of pathogenic bacteria often find a variety of bacteria, resulting in the actual pathogenic bacteria difficult to judge.
Read the detailed description
Based on the principle of 16SrDNA detection, this study developed an efficient and convenient gene chip, which can accurately identify and quantitatively analyze different types of pathogenic bacteria at the molecular level. Through this technology, it can significantly improve the diagnostic efficiency and accuracy of diabetic foot infection, provide patients with more timely treatment, reduce the risk of complications caused by infection, and improve the quality of life of patients.
Objective:
- Development of efficient gene chip: Design a gene chip that can rapidly detect pathogenic bacteria in diabetic foot infection wounds. By detecting the 16SrDNA sequence, the chip can identify a variety of pathogenic bacteria and provide accurate data support for clinical diagnosis
- Evaluate the difference in detection time between gene-chip detection technology and traditional schemes: traditional bacterial culture and identification methods usually take several days, but this study aims to shorten the detection time (i.e. the time from taking wound samples to getting pathogenic bacteria detection results) to several hours through gene-chip technology, so as to improve the diagnostic efficiency and obtain pathogenic bacteria information in time
- Compare the sensitivity and specificity of gene chip and traditional methods (such as bacterial culture) in detecting pathogenic bacteria, and then obtain the changes in the diagnostic accuracy of gene chip technology: The Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and other key diagnostic indicators of the pathogen were tested for specificity of diabetic foot infection, and the diagnostic accuracy of specificity was verified by comparing with traditional bacterial specificity Methods:This study is a scientific research project carried out in the laboratory. Through consulting the common bacterial strains cultured by diabetic foot infection in our hospital, the probe is made by adding anaerobic bacterial strains according to the literature. Informed consent was signed, about 60 subjects were recruited according to inclusion and exclusion criteria, and more than three specimens were collected for each subject. One was used to analyze pathogenic bacteria by conventional bacterial culture method; One pathogen was sequenced using conventional 16SrDNA; A gene chip analysis, using quantitative chip technology, to determine the content of each bacteria, with the highest content of bacteria reference as a pathogen. The sequencing result of bacterial content detected by bacterial 16SrDNA chip, the highest content, should be consistent with the conventional bacterial culture results.
- Conditions
- Diabetic Foot Disease, Diabetic Foot Ulcer, Diabetes
- Being tested
- The infected wound of the patient's foot ulcer was collected
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The infected wound of the patient's foot ulcer was collectedOther
The infected wound of the patient's foot ulcer was collected
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of gene chips:Sensitivity, Specificity, Positive Predictive Value (PPV), NegativePredictive Value (NPV)
Measured: through study completion, an average of 1 year
The time (in minutes) taken for diagnosis using the gene chip method compared to the traditional method.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
The time (in days) required for ulcer healing using the gene chip method compared to the traditional method.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start31 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Weiqing, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777810
- Sponsor's protocol ID
- CCEMD-20241002
- Status last verified
- Nov 2024
- First submitted
- 10 Dec 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Identification and Quantitative Analysis of Pathogenic Bacteria of Diabetic Foot Ulcer Infection
- ClinicalTrials.gov ID
- NCT06777810
- Acronym / sponsor ID
- CCEMD-20241002
- Conditions
- Diabetic Foot Disease, Diabetic Foot Ulcer, Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Jan 2025 (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.
The objective of this study is to design and develop a gene chip for detecting pathogenic bacteria in diabetic foot infection wounds. This innovative gene chip technology enables rapid and accurate identification of pathogens at the site of infection by detecting the 16SrDNA sequence of pathogenic bacteria.
Diabetic foot infection is a common serious complication in diabetic patients, often accompanied by complex pathogenic bacteria population, and due to the variety of infection types, traditional pathogen detection methods are time-consuming and low accuracy, patients may miss the best treatment opportunity. Now commonly used genetic identification of pathogenic bacteria often find a variety of bacteria, resulting in the actual pathogenic bacteria difficult to judge.
Detailed description
Based on the principle of 16SrDNA detection, this study developed an efficient and convenient gene chip, which can accurately identify and quantitatively analyze different types of pathogenic bacteria at the molecular level. Through this technology, it can significantly improve the diagnostic efficiency and accuracy of diabetic foot infection, provide patients with more timely treatment, reduce the risk of complications caused by infection, and improve the quality of life of patients.
Objective:
- Development of efficient gene chip: Design a gene chip that can rapidly detect pathogenic bacteria in diabetic foot infection wounds. By detecting the 16SrDNA sequence, the chip can identify a variety of pathogenic bacteria and provide accurate data support for clinical diagnosis
- Evaluate the difference in detection time between gene-chip detection technology and traditional schemes: traditional bacterial culture and identification methods usually take several days, but this study aims to shorten the detection time (i.e. the time from taking wound samples to getting pathogenic bacteria detection results) to several hours through gene-chip technology, so as to improve the diagnostic efficiency and obtain pathogenic bacteria information in time
- Compare the sensitivity and specificity of gene chip and traditional methods (such as bacterial culture) in detecting pathogenic bacteria, and then obtain the changes in the diagnostic accuracy of gene chip technology: The Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and other key diagnostic indicators of the pathogen were tested for specificity of diabetic foot infection, and the diagnostic accuracy of specificity was verified by comparing with traditional bacterial specificity Methods:This study is a scientific research project carried out in the laboratory. Through consulting the common bacterial strains cultured by diabetic foot infection in our hospital, the probe is made by adding anaerobic bacterial strains according to the literature. Informed consent was signed, about 60 subjects were recruited according to inclusion and exclusion criteria, and more than three specimens were collected for each subject. One was used to analyze pathogenic bacteria by conventional bacterial culture method; One pathogen was sequenced using conventional 16SrDNA; A gene chip analysis, using quantitative chip technology, to determine the content of each bacteria, with the highest content of bacteria reference as a pathogen. The sequencing result of bacterial content detected by bacterial 16SrDNA chip, the highest content, should be consistent with the conventional bacterial culture results.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic foot infection patients
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- Gender: males and females
- Patients diagnosed with diabetic foot infection with an infected wound
- It can provide sufficient infected wound samples (≥5mm³ infected wound tissue samples or ≥100μL infected wound secretions) and can be used for detection and analysis of gene chips
- No history of antibiotic therapy prior to sampling (within 4 weeks) or known failure to respond to antibiotic therapy (failure to respond to ≥2 antibiotics)
Key exclusion criteria (6 listed)
- Patients with undiagnosed diabetic foot infection
- Patients who had received antibiotics within 4 weeks prior to sampling
- Complicated with serious systemic disease (e.g., malignant tumor, severe cardiopulmonary insufficiency, etc.)
- Pregnant or lactating women
- Cognitive impairment or inability to cooperate with the research process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The infected wound of the patient's foot ulcer was collectedThe infected wound of the patient's foot ulcer was collected | Other | – |
Primary outcome
Diagnostic accuracy of gene chips:Sensitivity, Specificity, Positive Predictive Value (PPV), NegativePredictive Value (NPV)
Time frame: through study completion, an average of 1 year
The time (in minutes) taken for diagnosis using the gene chip method compared to the traditional method.
Time frame: through study completion, an average of 1 year
1 secondary outcome
The time (in days) required for ulcer healing using the gene chip method compared to the traditional method.
Time frame: through study completion, an average of 1 year
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 16 Jan 2025.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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 Disease and Diabetic Foot Ulcer, run by Shanghai Jiao Tong University School of Medicine 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Jan 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 Weiqing Wang, MD, PHD (008621-64370045, wqingw61@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of gene chips:Sensitivity, Specificity, Positive Predictive Value (PPV), NegativePredictive Value (NPV) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2025.