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

March 24, 2015 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Grau du Roi, France, 30240
        • CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
    • Gard
      • Nîmes Cedex 09, Gard, France, 30029
        • Centre Hospitalier Universitaire de Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Bone scintigraphy
Bone scintigraphy of the affected area
Procedure: Leukoscan
Scintigraphy with labeled neutrophils
Procedure: PET / CT
PET / CT of the affected area
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference between AUCs for PET/CT scan and scintigraphy
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Sophie Schuldiner, MD, Centre Hospitalier Universitaire de Nîmes
  • Principal Investigator: Nathalie Jourdan, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI/2009/SJ-01
  • 2010-020160-38 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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