Diabetic Foot Ulcers (DFU) Nutritional, Metabolic, Endocrine Diabetic Foot Ulcers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Presence of likely pathogens (e.g. Staphylococcus aureus, Streptococci, Enterobacter aerogenes, Psuedomonas, Corynebacterium species, Fusobacterium species, Bacteriodes fragilis, Prevotella bivia) 2. Presence of antimicrobial resistance among likely pathogens 3. Number of species detected per specimen | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Appropriateness of empirical antibiotic therapy 2. Number and presence of pathogens isolated (conventional plating and molecular techniques) 3. Adverse events 4. Sampling costs | — |
Countries
United Kingdom