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Comparing swabs and samples in collecting information about infection in diabetic foot ulceration

COncordance in DIabetic Foot Infection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN52608451
Enrollment
400
Registered
2011-09-21
Start date
2011-10-01
Completion date
Unknown
Last updated
2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcers (DFU) Nutritional, Metabolic, Endocrine Diabetic Foot Ulcers

Interventions

Patient attending clinic found to have a clinically infected DFU that the clinician feels requires antibiotic treatment. If the person is able to give informed consent they are asked to consent to hav

Sponsors

University of Leeds (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026