Outline proposal

This will be an internet-based survey of the response to routine management in a large number of centres in different countries. We will approach clinicians in North America (through EIN, American Diabetes Association, American Podiatric Medicine Association?), the UK (through the Diabetes UK, the Federation of Infection Societies), continental Europe (through the Diabetic Foot Study Group of the European Association for the Study of Diabetes), and the rest of the world (through the International Working Group on the Diabetic Foot of the International Diabetes Federation) and invite them to participate in the study. They will be asked initially to express their interest and to give anonymised information on their professional training, their place of work and their usual approach to management.

Selected clinicians will then be asked to enter details of the next newly presenting case of osteomyelitis (definite or probable based on the clinician's definitions-see below) of the foot in a patient with diabetes that presents or is referred to them. Eligibility to enroll a case will remain open for only 6 months from the start of the recruitment phase of the project. Once the clinician registers a case, he/she will be also asked to register every other case that presents or is referred to him/her in the succeeding 4 weeks. This design is intended to minimise the potential problem of case selection.

Details of each case wil be entered online with the information being anonymised and cases identifed only by study number. We will record the site of registration, gender and date of birth to eliminate the possibility of duplicate entry. Following initial registration, participants will be invited through the use of structured questionnaires to provide details on interventions and outcomes at intervals up to 12 months after case enrollment.

We will direct our analysis towards determining the actual rates of clinical success and failure of the primary intervention, as well as differences observed among various centres, communities and countries, among different pre-defined patient groups and among patients managed in different ways. Appendix A lists the principles of the analysis. Apart from determining the overall incidence of apparent cure or remission, the principal aim will be to determine whether the outcome in those whose management is primarily non-surgical is any different from that in those who undergo early surgical excision of infected bone. We will also seek differences in outcomes by specific agent and duration of antibiotic therapy, by routes of antibiotic therapy (intravenous or oral) and by whether or not the antibiotic regimen was selected by the results of microbiological studies. We will also determine if outcome of treatment correlates with any adjunctive treatments, e.g., hyperbaric oxygen, granulocyte-colony stimulating factor. We will analyse data using appropriate correlations and regression analyses.

Diagnosis of Osteomyelitis

There are no universally agreed criteria for the diagnosis of osteomyelitis of the foot in persons with diabetes. For this reason, we will accept a diagnosis of osteomyelitis made using the methods normally employed by the participating clinicians and centres. This may include using one or any combination of: clinical findings (e.g. depth of ulcer, visible bone, probe-to-bone test, long term clinical follow-up), hematological tests (e.g., erythrocyte sedimentation rate, C-reactive protein), imaging tests (e.g. plain radiographs, nuclear medicine studies, computed tomography, magnetic resonance and other scans), or bone biopsy (for histology or culture). Investigators will be asked to rate their diagnosis of osteomyelitis as "definite" or "probable" and they will have the option to revise this diagnosis when further evidence becomes available. We will then apply the preliminary definitions recently developed by the International Working Group on the Diabetic Foot Osteomyelitis Committee to see how the outcomes correlate with the clinician-defined cases.

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Last modified: 05/01/08