Identification of Pathogenic Bacteria of Diabetes Foot Ulcer

NCT06777810 | Not Yet Recruiting DMC

• 1 other identifier: CCEMD-20241002
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Disease; Diabetic Foot Ulcer; Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• 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

Interventions

The infected wound of the patient's foot ulcer was collected OTHER

The infected wound of the patient's foot ulcer was collected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic foot infection patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

National Clinical Medical Research Center for Metabolic Diseases (Shanghai)

Shanghai, China

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Weiqing Wang, MD, PHD

CONTACT

008621-64370045; wqingw61@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 16, 2025
• Study Start: January 31, 2025
• Primary Completion: January 31, 2026
• Study Completion: June 30, 2026
• Last Updated: January 16, 2025

Record last verified: 2024-11

Locations

CN (1)