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

Osteoarthritis Clinical Trial

— ISEOD  

Official title:

Positron Emission Tomography - Computed Tomography (PET/CT) Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01322256
• Other study ID #: AOI/2009/SJ-01
• Secondary ID: 2010-020160-38
• Status: Terminated
• Phase: N/A
• First received: March 23, 2011
• Last updated: March 24, 2015
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetic Foot
• Osteoarthritis

Intervention

Procedure:
• 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.

Biological:
• Bloodwork
CRP and procalcitonin are measured in the pre-inclusion work up.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi	Le Grau du Roi
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between AUCs for PET/CT scan and scintigraphy		1 year	No