The infected wound of the patient's foot ulcer was collected
The infected wound of the patient's foot ulcer was collected: The infected wound of the patient's foot ulcer was collected
Study 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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years old
2. Gender: males and females
3. Patients diagnosed with diabetic foot infection with an infected wound
4. 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
5. 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)
6. 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
Exclusion Criteria:
1. Patients with undiagnosed diabetic foot infection
2. Patients who had received antibiotics within 4 weeks prior to sampling
3. Complicated with serious systemic disease (e.g., malignant tumor, severe cardiopulmonary insufficiency, etc.)
4. Pregnant or lactating women
5. Cognitive impairment or inability to cooperate with the research process
6. History of allergies or allergies to materials related to the study
Primary outcome measure(s)
Diagnostic accuracy of gene chips:Sensitivity, Specificity, Positive Predictive Value (PPV), NegativePredictive Value (NPV) — 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. — through study completion, an average of 1 year
Trial sites (1)
Facility
City
Region
Status
National Clinical Medical Research Center for Metabolic Diseases (Shanghai)
Shanghai
China
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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