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White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis

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ClinicalTrials.gov Identifier: NCT02927678
Recruitment Status : Unknown
Verified September 2016 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Diabetic Foot Osteomyelitis Other: white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging

Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of White Blood Cell SPECT/CT in Monitoring Antibiotic Treatment in Patients With Diabetic Foot Osteomyelitis
Study Start Date : January 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a clinical and radiological diagnosis of osteomyelitis were included in two diabetic centers
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927678


Contacts
Contact: Julien Vouillarmet, MD (4) 78 86 14 89 ext +33 julien.vouillarmet@chu-lyon.fr

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02927678     History of Changes
Other Study ID Numbers: 69HCL16_0597
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: September 2016

Keywords provided by Hospices Civils de Lyon:
Diabetic foot
Osteomyelitis
Antibiotic treatment
White Blood Cell SPECT/CT

Additional relevant MeSH terms:
Diabetic Foot
Osteomyelitis
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases