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

Primary Purpose

Diabetic Foot, Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bone scintigraphy
Leukoscan
PET / CT
Bone biopsy
Bloodwork
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Foot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier Universitaire de Nîmes
  • CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Included patients

Arm 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

Outcomes

Primary Outcome Measures

The difference between AUCs for PET/CT scan and scintigraphy

Secondary Outcome Measures

Full Information

First Posted
March 23, 2011
Last Updated
March 24, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01322256
Brief Title
PET/CT Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
The study has proven to be infeasible.
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Osteoarthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Included patients
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Bone scintigraphy
Intervention Description
Bone scintigraphy of the affected area
Intervention Type
Procedure
Intervention Name(s)
Leukoscan
Intervention Description
Scintigraphy with labeled neutrophils
Intervention Type
Procedure
Intervention Name(s)
PET / CT
Intervention Description
PET / CT of the affected area
Intervention Type
Procedure
Intervention Name(s)
Bone biopsy
Intervention Description
A bone biopsy is performed during pre-inclusion work up.
Intervention Type
Biological
Intervention Name(s)
Bloodwork
Intervention Description
CRP and procalcitonin are measured in the pre-inclusion work up.
Primary Outcome Measure Information:
Title
The difference between AUCs for PET/CT scan and scintigraphy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Schuldiner, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nathalie Jourdan, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes Cedex 09
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
City
Le Grau du Roi
ZIP/Postal Code
30240
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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