White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis

Diabetic Foot Osteomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02927678
• Other study ID #: 69HCL16_0597
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2016
• Last updated: October 6, 2016
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Hospices Civils de Lyon
• Contact: Julien Vouillarmet, MD
• Phone: (4) 78 86 14 89
• Email: julien.vouillarmet[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Osteomyelitis
• Osteomyelitis

Intervention

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

Locations

Country	Name	City	State
France	Service d'Endocrinologie-Diabétologie-Maladies de la nutrition, GH Sud, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No