None listed
Conditions
Brief summary
Probe-to-bone test (PTB) is a simple bedside clinical test to aid in the diagnosis of diabetic foot osteomyelitis (OM). While it has been shown to be useful (especially in a high-risk cohort), diagnosis of OM is supported by additional tests such as X-rays and blood tests for markers of infection. The gold standard test for diagnosing OM is a bone biopsy, which is often not routinely performed due to the invasiveness of the procedure and the difficulty with accessing clinicians trained in performing this. Patients with diabetic foot ulcers and positive PTB tests are often treated for OM with prolonged courses of antibiotics despite normal X-rays and/or normal biomarkers of infection. This study aims to evaluate the safety and feasibility of treating patients with diabetic foot ulcers and positive PTB test with shorter courses of antibiotic therapy in a low-risk (outpatient) setting.
Interventions
Probe-to-bone test procedure
-Bedside clinical test performed by inserting a blunt metal probe into an ulcer and palpating for bone at the base
-This test will be performed by a trained clinician (podiatrist or experienced doctor) at initial assessment
-Antibiotic therapy will be commenced as soon as possible after a positive result (ideally on the same day)
Intervention group: 2 weeks antibiotic therapy
-Antibiotic therapy, including agent, dosing and route of administration, will be at the di
Probe-to-bone test procedure -Bedside clinical test performed by inserting a blunt metal probe into an ulcer and palpating for bone at the base -This test will be performed by a trained clinician (podiatrist or experienced doctor) at initial assessment -Antibiotic therapy will be commenced as soon as possible after a positive result (ideally on the same day) Intervention group: 2 weeks antibiotic therapy -Antibiotic therapy, including agent, dosing and route of administration, will be at the discretion of the treating clinicians based on results of any relevant microbiological culture and susceptibility results, such as wound swab cultures. -Common antibiotic regimens likely to be used will include oral glucloxacillin 500mg QID, oral Amoxicillin/clavulanate 800/125mg BD, oral Clindamycin 450mg TDS, etc -Adherence will be assessed via a medication adherence questionnaire given to the patient at each follow-up visit. This questionnaire is specifically designed for this study by the investigators
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Adult patient (greater than or equal to 18 years) with diabetic foot ulcer -Ulcer with positive probe-to-bone test -X-ray performed within 72 hours of enrollment demonstrating no changes suggestive of osteomyelitis at the site of the ulcer by the reporting radiologist -Willing and able to consent
Exclusion criteria
-Systemic antimicrobial therapy for >7 days in the 30 days prior to initial enrollment -Systemic signs of sepsis based on SIRS criteria -Initial surgical therapy deemed more appropriate than medical management alone of diabetic foot infection -Known pregnancy
Outcome results
None listed