White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis

October 6, 2016 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Service d'Endocrinologie-Diabétologie-Maladies de la nutrition, GH Sud, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a clinical and radiological diagnosis of osteomyelitis were included in two diabetic centers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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
one year after the end of the antibiotic treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of osteomyelitis remission at one year after a 6 weeks antibiotics duration, evaluated by white blood cell SPECT/CT
Time Frame: 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
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.
Time Frame: one year after the end of the antibiotic treatment
Sensibility ratio= number of true positive /number of (true positive+false negative)
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.
Time Frame: one year after the end of the antibiotic treatment
Specificity ratio= number of true negative /number of (true negative+false positive)
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.
Time Frame: one year after the end of the antibiotic treatment
Positive predictive value = number of true positive / number of (true positive+false positive)
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.
Time Frame: one year after the end of the antibiotic treatment
Negative predictive value = number of true negative / number of (true negative+false negative)
one year after the end of the antibiotic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 6, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 7, 2016

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0597

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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