Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof William Jeffcoate


Contact details

Foot Ulcer Trials Unit
David Evans Medical Research Centre
Nottingham University Hospitals NHS Trust
City Campus
United Kingdom
+44 (0)115 840 5859

Additional identifiers

EudraCT number number

Protocol/serial number


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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Osteomyelitis of the foot in diabetes


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



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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

France, Germany, Italy, Sweden, United Kingdom

Trial participating centre

Foot Ulcer Trials Unit
United Kingdom

Sponsor information


Nottingham University Hospitals NHS Trust (UK)

Sponsor details

Queens Medical Centre
Derby Road
United Kingdom
+44 (0)115 970 9049

Sponsor type




Funder type


Funder name

Moulton Charitable Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes

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