Clinical trial NCT02927678: White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis
Official title: Assessment of White Blood Cell SPECT/CT in Monitoring Antibiotic Treatment in Patients With Diabetic Foot Osteomyelitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot Osteomyelitis
Keywords: Diabetic foot
Osteomyelitis
Antibiotic treatment
White Blood Cell SPECT/CT
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a clinical and radiological diagnosis of osteomyelitis were included in two diabetic centers

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: one year after the end of the antibiotic treatment
Secondary outcomes:
measure: Rate of osteomyelitis remission at one year after a 6 weeks antibiotics duration, evaluated by white blood cell SPECT/CT
timeFrame: one year after the end of the antibiotic treatment
measure: Sensibility ration of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year.
timeFrame: one year after the end of the antibiotic treatment
measure: Specificity ratio of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year.
timeFrame: one year after the end of the antibiotic treatment
measure: 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.
timeFrame: one year after the end of the antibiotic treatment
measure: 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.
timeFrame: one year after the end of the antibiotic treatment
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service d'Endocrinologie-Diabétologie-Maladies de la nutrition, GH Sud, Hospices Civils de Lyon
Study officials:
References:
citation: 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.
citation: 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.