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

Not Applicable

Terminated

• Conditions: Diabetic Foot; Osteoarthritis
• Interventions: Procedure: Bone scintigraphy; Procedure: Leukoscan; Procedure: PET / CT; Procedure: Bone biopsy; Biological: Bloodwork

• Registration Number: NCT01322256
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Study Start: 2012-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Included patients	Bone scintigraphy	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
Included patients	Bone biopsy	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
Included patients	Leukoscan	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
Included patients	PET / CT	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
Included patients	Bloodwork	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

Primary Outcome Measures

Name	Time	Method
The difference between AUCs for PET/CT scan and scintigraphy	1 year

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes Cedex 09, Gard, France

CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi; 🇫🇷 Le Grau du Roi, France