Contact information
Type
Scientific
Primary contact
Prof William Jeffcoate
ORCID ID
Contact details
Foot Ulcer Trials Unit
David Evans Medical Research Centre
Nottingham University Hospitals NHS Trust
City Campus
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 840 5859
william.jeffcoate@futu.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of the use of bone biopsy to determine antibiotic choice in the management of osteomyelitis of the foot in diabetes: BBAB study
Acronym
BBAB
Study hypothesis
There is no consensus on the best treatment of osteomyelitis of the foot in diabetes - which is a common and potentially disabling problem. Many centres choose antibiotics with a broad spectrum antibacterial activity, and prescribe them for many weeks or months. While this approach is successful in the majority of cases and can reduce the need for surgery, it is associated with an increased risk of side-effects (including infection with bacteria, such as Clostridium difficile) and encourages the emergence of resistant organisms, such as methicillin resistant Staphylococcus aureus [MRSA]).
Some expert bodies (including the Infectious Diseases Society of America and the International Working Group on the Diabetic Foot of the International Diabetes Federation) recommend that antibiotic choice is targeted on the basis of the results of culture of a specimen of bone obtained under local anaesthetic (bone biopsy), but this is not widely practised. Nevertheless, the use of bone biopsy in this way appeared to improve outcome in one recent study from France, even though this study was flawed by not being randomised and it is possible that other factors contributed to the differences observed.
There is a clear need to establish the benefits and adverse effects of undertaking bone biopsy to guide antibiotic use and that is the purpose of this study. If the apparent benefit of bone biopsy is established, it will have an immediate impact on routine clinical care.
Ethics approval
Leicestershire, Northamptonshire and Rutland REC 2 on the 11th August 2008.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Osteomyelitis of the foot in diabetes
Intervention
Patients will be randomised to two groups. The first will have a bone biposy, the culture of which will allow the investigators to target the antibiotics given. The second group will not be biopsied but will have broad spectrum antibiotics given. Both groups will have treatment for at least six weeks with antibiotics, but will be followed up for six months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The incidence at six months of apparent arrest of bone infection without amputation, measured at six months.
Secondary outcome measures
1. Incidence and level of amputation (major or minor)
2. Survival: death related directly or not to infection of the foot
3. Incidence of reactivated or recurrent infection
4. Prevalence of active ulceration (persistent, reactivated or recurrent) at the end of the study
5. Days in hospital (for reasons both related or not to the infection)
6. Complications of bone biopsy
7. Adjustment of chosen antibiotic regimen
8. Duration of antibiotic treatment (intravenous and oral)
9. Infection or colonisation after the initiation of antibiotic treatment of ulcers on either foot (or other clinical infections) with MRSA and/or multiresistant organisms (MDROs): bacteria that are resistant to antibiotics which are typically used in their treatment, e.g., MRSA, vancomycin-resistant enterococci (VRE), or extended-spectrum beta lactamases (ESBL) producing gram-negative bacilli
10. Other superinfections, side-effects and adverse events (including C. difficile diarrhoea) occurring at any stage in the period of follow-up
11. Comparison of the results of baseline microbiological sampling from superficial soft tissue, deep soft tissue and bone
12. Measurement of health outcome, by results of EuroQoL instrument (EQ-5D) at 6 and 12 months after randomisation, and change from baseline
Outcomes will be measured at six months.
Overall trial start date
01/09/2008
Overall trial end date
31/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type 1 or type 2 diabetes mellitus
2. Aged greater than or equal to 18 years, either sex
3. Previously undiagnosed infection of bone in the foot (excluding disease limited to the tibia and or fibula), which is either definite or strongly suspected on clinical grounds
4. Able and willing to give written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Critical ischaemia: clinical or other criteria which suggest to the managing clinician that bone biopsy is relatively contraindicated
2. Frailty or disability which would mean that participation in the study might have an adverse effect on patient well being and mood
3. Pregnancy or the possibility of the occurrence of pregnancy during the study period
4. Those who are unwilling or unable to consent
Recruitment start date
01/09/2008
Recruitment end date
31/08/2010
Locations
Countries of recruitment
France, Germany, Italy, Sweden, United Kingdom
Trial participating centre
Foot Ulcer Trials Unit
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
Nottingham University Hospitals NHS Trust (UK)
Sponsor details
Queens Medical Centre
Derby Road
Nottingham
NG2 2UH
United Kingdom
+44 (0)115 970 9049
david.hetmanski@nottingham.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Moulton Charitable Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary