PET/CT Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot (ISEOD)

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Osteoarthritis; Diabetic Foot

Treatments: Procedure: Leukoscan; Procedure: Bone scintigraphy; Procedure: PET / CT; Biological: Bloodwork; Procedure: Bone biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01322256

AOI/2009/SJ-01

2010-020160-38 (Other Identifier)

Details and patient eligibility

About

The investigators' primary objective is to assess the predictive power of PET/CT scanning in the evolution of infectious osteoarthritis of the diabetic diabetic after antibiotic therapy prescribed by national and international recommendations.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must have given his/her informed and signed consent
• 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 participating in another study
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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12 participants in 1 patient group

Included patients

Experimental group

Description:

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

Treatment:

Procedure: Leukoscan

Procedure: PET / CT

Biological: Bloodwork

Procedure: Bone biopsy

Procedure: Bone scintigraphy