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White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02927678
Enrollment
56
Registered
2016-10-07
Start date
2014-01-31
Completion date
2016-12-31
Last updated
2016-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Osteomyelitis

Keywords

Diabetic foot, Osteomyelitis, Antibiotic treatment, White Blood Cell SPECT/CT

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.

Interventions

OTHERwhite blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 treatmentThe 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

MeasureTime frameDescription
Rate of osteomyelitis remission at one year after a 6 weeks antibiotics duration, evaluated by white blood cell SPECT/CTone year after the end of the antibiotic treatmentThe 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
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 treatmentSensibility 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 treatmentSpecificity ratio= number of true negative /number of (true negative+false positive)
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 treatmentPositive predictive value = number of true positive / number of (true positive+false positive)
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 treatmentNegative predictive value = number of true negative / number of (true negative+false negative)

Countries

France

Contacts

Primary ContactJulien Vouillarmet, MD
julien.vouillarmet@chu-lyon.fr(4) 78 86 14 89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026