NCT06777810|Not Yet RecruitingDMC
Identification of Pathogenic Bacteria of Diabetes Foot Ulcer
Genetic Identification and Quantitative Analysis of Pathogenic Bacteria of Diabetic Foot Ulcer Infection
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Genetic Identification and Quantitative Analysis of Pathogenic Bacteria of Diabetic Foot Ulcer Infection
Sponsor study identifier
observational
60
1 country
1
Study Start
January 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2024
Actual (reported)January 16, 2025
Actual (reported)January 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
The time (in days) required for ulcer healing using the gene chip method compared to the traditional method.
through study completion, an average of 1 year
The infected wound of the patient's foot ulcer was collected
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Diabetic foot infection patients
National Clinical Medical Research Center for Metabolic Diseases (Shanghai)
Shanghai, China
First Submitted
December 10, 2024
First Posted
January 16, 2025
Study Start
January 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 31, 2026
Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 16, 2025
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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