PET/CT Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot
NCT ID: NCT01322256
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2012-10-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Included patients
Patients included in the study according to stated inclusion and exclusion criteria
Intervention: Bone scintigraphy Intervention: Leukoscan Intervention: PET / CT Intervention: Bone biopsy Intervention: Bloodwork
Bone scintigraphy
Bone scintigraphy of the affected area
Leukoscan
Scintigraphy with labeled neutrophils
PET / CT
PET / CT of the affected area
Bone biopsy
A bone biopsy is performed during pre-inclusion work up.
Bloodwork
CRP and procalcitonin are measured in the pre-inclusion work up.
Interventions
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Bone scintigraphy
Bone scintigraphy of the affected area
Leukoscan
Scintigraphy with labeled neutrophils
PET / CT
PET / CT of the affected area
Bone biopsy
A bone biopsy is performed during pre-inclusion work up.
Bloodwork
CRP and procalcitonin are measured in the pre-inclusion work up.
Eligibility Criteria
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Inclusion Criteria
* The patient must be insured or beneficiary of a health insurance plan
* Patient has type I or type II diabetes
* Patient consulting in the department of Metabolic and Endocrine Diseases (Caremeau Hospital) or the department of Nutritional Diseases and Diabetology (Grau de Roi Medical Center) at the Nîmes University Hospital
* Patient has infected osteoarthritis of the foot according to the International Working Group on the Diabetic Foot with a probability \> 50% (score \>= 2).
Exclusion Criteria
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* Patient has severe sepsis or a stage 4 infection according to the international consensus on the diabetic foot
* Patient has severe renal insufficiency as defined by glomerular filtration rate \< 30ml/min/1.73 m\^2, calculated according to the MDRD equation, and is not undergoing dialysis
* Patient has a contra-indication for an MRI
* pacemaker
* intracranial clips
* metallic inclusions
* severe claustrophobia
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Sophie Schuldiner, MD
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire de Nîmes
Nathalie Jourdan, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nîmes
Locations
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Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, France
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau-du-Roi, , France
Countries
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Other Identifiers
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2010-020160-38
Identifier Type: OTHER
Identifier Source: secondary_id
AOI/2009/SJ-01
Identifier Type: -
Identifier Source: org_study_id
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