Identification of Pathogenic Bacteria of Diabetes Foot Ulcer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Jiao Tong University School of Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Diabetic foot infection patients
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
The infected wound of the patient's foot ulcer was collected
Other interventionThe infected wound of the patient's foot ulcer was collected
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of gene chips:Sensitivity, Specificity, Positive Predictive Value (PPV), NegativePredictive Value (NPV)
Time frame
through study completion, an average of 1 year2
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 yearSecondary outcomes
1
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Jiao Tong University School of Medicine
Lead sponsor
Ruijin Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: