None listed
Conditions
Brief summary
We plan to determine if narrow (targeted) spectrum antibiotics have the same outcomes as broad spectrum antibiotics when treating mild or moderate diabetic foot infections. We know through research that often diabetic foot infections have two main bacteria present, and more often than not, these infections can be treated with a narrow targeted spectrum antibiotic.
Interventions
Participants are randomly assigned to receive either a narrow-spectrum antibiotic regimen or a broad-spectrum antibiotic regimen for treatment of their infected diabetic foot ulcer.
This treatment will be prescribed on a sliding scale dependant on participant response to infection.
The minimal duration of prescription will be 1 week, up to a maximum prescription of 3 weeks.
The narrow spectrum antibiotic prescription will be: Flucloxacillin or Dicloxacillin 500mg orally given 6 hourly. The
Participants are randomly assigned to receive either a narrow-spectrum antibiotic regimen or a broad-spectrum antibiotic regimen for treatment of their infected diabetic foot ulcer. This treatment will be prescribed on a sliding scale dependant on participant response to infection. The minimal duration of prescription will be 1 week, up to a maximum prescription of 3 weeks. The narrow spectrum antibiotic prescription will be: Flucloxacillin or Dicloxacillin 500mg orally given 6 hourly. The decision between Flucloxacillin and Dicloxacillin will be guided by the advice of the local health policy and the prescribing physician. If there is a true hypersensitivity to penicillin participants will be prescribed Clindamycin 450mg orally 8-hourly. The mode of administration for all treatment arms will be an oral tablet(s). Medication adherence will be encouraged through the use of short messaging service (text messaging) at the times the medication should be taken. Participants will also be provided with a diary to document when the dose should be taken.
Sponsors
South West Sydney Limb Preservation and Wound Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Type 1 or 2 Diabetes mellitus - Newly diagnosed (<14 days) infective signs of symptoms - No use of topical or systemic antimicrobial/antibiotic therapy 72 hours (3 days) prior to enrolment - Mild to moderate Diabetic Foot Infection (PEDIS grade 2-3, IDSA mild or moderate foot infection, WIfI grade 1-2) - Wound without bone involvement (Grade 1 and 2) - Age >18 years - Adequate peripheral vascular supply (good blood flow, measured as grade 0-2 WIfI)
Exclusion criteria
- Participants with chronic infective symptoms who have received multiple (>2) antibiotic regimens within the previous 4 weeks or greater - Proof of underlying bone involvement (osteomyelitis) based on; imaging (plain x-ray, computed tomography [CT], or magnetic resonance imaging [MRI]), clinical examination (exposed bone or positive probe to bone test) or culture/histopathology of bone specimen - Diabetic foot ulcer of small size - <2cm in surface area - Age under 18 years - Documented peripheral arterial disease with either; ankle brachial indices < or equal to 0.4, toe brachial indices <0.5, toe pressure <40mmHg - Pregnant women, women desiring pregnancy within the duration of the study, or those unwilling to practice contraception, women who are breastfeeding - Stage 4-5 chronic kidney disease and/or an estimated glomerular filtration rate (eGFR) of <30ml/min/m - Active liver disease as defined by an INR >2 (in the absence of oral anti-coagulation) and/or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 upper limit of normal (ULN) - Chronic liver disease as defined as clinical history of decompensating chronic liver disease (ascites, encephalopathy or variceal bleeding) - otherwise assessed by study investigators as unsuitable to take tissue via biopsy or unable to follow trial protocols
Outcome results
None listed