Bone Biopsy and AntiBiotics study

ISRCTN	ISRCTN14961624
DOI	https://doi.org/10.1186/ISRCTN14961624
Secondary identifying numbers	N/A

Submission date: 29/05/2008
Registration date: 09/06/2008
Last edited: 29/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof William Jeffcoate
Scientific

Foot Ulcer Trials Unit
David Evans Medical Research Centre
Nottingham University Hospitals NHS Trust
City Campus
Nottingham
NG5 1PB
United Kingdom

Phone	+44 (0)115 840 5859
Email	william.jeffcoate@futu.co.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	BBAB
Study objectives	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(s)	Leicestershire, Northamptonshire and Rutland REC 2 on the 11th August 2008.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2008
Completion date	31/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key 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
Key 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
Date of first enrolment	01/09/2008
Date of final enrolment	31/08/2010

Locations

Countries of recruitment

England
France
Germany
Italy
Sweden
United Kingdom

Study participating centre

Foot Ulcer Trials Unit

Nottingham
NG5 1PB
United Kingdom

Sponsor information

Nottingham University Hospitals NHS Trust (UK)
Hospital/treatment centre

Queens Medical Centre
Derby Road
Nottingham
NG2 2UH
England
United Kingdom

Phone	+44 (0)115 970 9049
Email	david.hetmanski@nottingham.ac.uk
Website	http://www.qmc.nhs.uk/
"ROR"	https://ror.org/05y3qh794

Funders

Funder type

Charity

Moulton Charitable Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

29/06/2016: No publications found, verifying study status with principal investigator