White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis

• Conditions: Diabetic Foot Osteomyelitis
• Interventions: Other: white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging

• Registration Number: NCT02927678
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2016-09
• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Study First Posted: 2016-10-07
• Last Update Posted: 2016-10-07
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

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Exclusion Criteria

• Indication for acute surgical bone resection or amputation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patients with osteomyelitis	white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging	Patients with a clinical and radiological diagnosis of osteomyelitis were included in two diabetic centers

Primary Outcome Measures

Name	Time	Method
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).	one year after the end of the antibiotic treatment	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

Secondary Outcome Measures

Name	Time	Method
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.	one year after the end of the antibiotic treatment	Negative predictive value = number of true negative / number of (true negative+false negative)
Rate of osteomyelitis remission at one year after a 6 weeks antibiotics duration, evaluated by white blood cell SPECT/CT	one year after the end of the antibiotic treatment	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
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.	one year after the end of the antibiotic treatment	Positive predictive value = number of true positive / number of (true positive+false positive)
Sensibility ration of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year.	one year after the end of the antibiotic treatment	Sensibility ratio= number of true positive /number of (true positive+false negative)
Specificity ratio of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year.	one year after the end of the antibiotic treatment	Specificity ratio= number of true negative /number of (true negative+false positive)

Trial Locations

Locations (1)

Service d'Endocrinologie-Diabétologie-Maladies de la nutrition, GH Sud, Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France