NCT02927678|Unknown
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
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Assessment of White Blood Cell SPECT/CT in Monitoring Antibiotic Treatment in Patients With Diabetic Foot Osteomyelitis
Sponsor study identifier
observational
56
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 6, 2016
Actual (reported)October 7, 2016
Actual (reported)December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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
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
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
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
Patients with a clinical and radiological diagnosis of osteomyelitis were included in two diabetic centers
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Patients with a clinical and radiological diagnosis of osteomyelitis were included in two diabetic centers
Service d'Endocrinologie-Diabétologie-Maladies de la nutrition, GH Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495, France
Vouillarmet J, Tordo J, Moret M, Michon P, Morelec I. 99mTc-white blood cell SPECT/CT to assess diabetic foot osteomyelitis remission: contribution of semi-quantitative scoring system. Nucl Med Commun. 2021 Jul 1;42(7):713-718. doi: 10.1097/MNM.0000000000001390.
Vouillarmet J, Moret M, Morelec I, Michon P, Dubreuil J. Application of white blood cell SPECT/CT to predict remission after a 6 or 12 week course of antibiotic treatment for diabetic foot osteomyelitis. Diabetologia. 2017 Dec;60(12):2486-2494. doi: 10.1007/s00125-017-4417-x. Epub 2017 Sep 2.
First Submitted
October 6, 2016
First Posted
October 7, 2016
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 7, 2016
Record last verified: 2016-09
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