Bone Biopsy and AntiBiotics study

Not Applicable

Completed

• Conditions: Osteomyelitis of the foot in diabetes; Musculoskeletal Diseases; osteomyelitis

• Registration Number: ISRCTN14961624
• Lead Sponsor: ottingham University Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-09
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence at six months of apparent arrest of bone infection without amputation, measured at six months.