White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis

Study Overview
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Brief Summary
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Osteomyelitis is a risk factor for lower extremity amputation in diabetic people. Antibiotic therapy allows a remission in 60 to 80% of cases. However the optimal duration of antibiotic therapy remains controversy due to the absence of validated marker of osteomyelitis remission. We have previously shown that the negativity of white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging at the end of treatment allowed to predict remission of osteomyelitis at 1 year in all cases. A positive imaging was associated with recurrence in 70% of cases. The aim of our study was to evaluate prospectively the interest of white blood cell SPECT/CT to set the duration of antibiotic therapy.

Official Title
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Assessment of White Blood Cell SPECT/CT in Monitoring Antibiotic Treatment in Patients With Diabetic Foot Osteomyelitis

Conditions
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Diabetic Foot Osteomyelitis

Intervention / Treatment
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* Other: white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Diabetes Osteomyelitis defined by soft tissue infection and/or positive probe-to-bone test and suggestive signs of osteomyelitis on plain-X-Ray Exclusion Criteria: - Indication for acute surgical bone resection or amputation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic patients with osteomyelitis<br>Patients with a clinical and radiological diagnosis of osteomyelitis were included in two diabetic centers | Other: white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of remission of osteomyelitis at one year after the cessation of antibiotic treatment, evaluated by white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography). | The outcome measure was reviewed by patient examination at least 12 months after completion of antibiotic treatment. A remission was defined by : the absence of recurrent infection at the initial site no need for surgical bone resection or amputation | one year after the end of the antibiotic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of osteomyelitis remission at one year after a 6 weeks antibiotics duration, evaluated by white blood cell SPECT/CT | The outcome measure was reviewed by patient examination at least 12 months after completion of antibiotic treatment. A remission was defined by : the absence of recurrent infection at the initial site no need for surgical bone resection or amputation | one year after the end of the antibiotic treatment | 
| Sensibility ration of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year. | Sensibility ratio= number of true positive /number of (true positive+false negative) | one year after the end of the antibiotic treatment | 
| Specificity ratio of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year. | Specificity ratio= number of true negative /number of (true negative+false positive) | one year after the end of the antibiotic treatment | 
| Positive predictive value of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year. | Positive predictive value = number of true positive / number of (true positive+false positive) | one year after the end of the antibiotic treatment | 
| Negative predictive value of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year. | Negative predictive value = number of true negative / number of (true negative+false negative) | one year after the end of the antibiotic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot, Osteomyelitis, Antibiotic treatment, White Blood Cell SPECT/CT