Condition category
Musculoskeletal Diseases
Date applied
29/05/2008
Date assigned
09/06/2008
Last edited
29/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.futu.co.uk/

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

http://www.qmc.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

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