Comparing swabs and samples in collecting information about infection in diabetic foot ulceratio
- Conditions
- Diabetic Foot Ulcers (DFU)Nutritional, Metabolic, EndocrineDiabetic Foot Ulcers
- Registration Number
- ISRCTN52608451
- Lead Sponsor
- niversity of Leeds (UK)
- Brief Summary
1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23293263 2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29391370
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
1. Patient has a diagnosis of diabetes (either type 1 or type 2)
2. Patient has a suspected ulcer infection with or without bone infection, based on clinical signs and symptoms using the Infectious Diseases Society of America / International Working Group on the Diabetic Foot (IDSA / IWGDF ? IWGDF, 2003) criteria and the judgment of the Investigator
3. The clinical plan is to treat the patient with antibiotics for their infected ulcer
4. Patient is at least 18 years of age at the time of signing the informed consent form
5. Patient is able to understand and willing to give written informed consent to participate in the study
1. The clinician deems it inappropriate to take a curette sample or a swab sample for any reason
2. The patient has already been recruited to the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Presence of likely pathogens (e.g. Staphylococcus aureus, Streptococci, Enterobacter aerogenes, Psuedomonas, Corynebacterium species, Fusobacterium species, Bacteriodes fragilis, Prevotella bivia)<br>2. Presence of antimicrobial resistance among likely pathogens<br>3. Number of species detected per specimen
- Secondary Outcome Measures
Name Time Method 1. Appropriateness of empirical antibiotic therapy<br>2. Number and presence of pathogens isolated (conventional plating and molecular techniques)<br>3. Adverse events<br>4. Sampling costs