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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01322256
Recruitment Status : Terminated (The study has proven to be infeasible.)
First Posted : March 24, 2011
Last Update Posted : March 25, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Osteoarthritis Procedure: Bone scintigraphy Procedure: Leukoscan Procedure: PET / CT Procedure: Bone biopsy Biological: Bloodwork Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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 Start Date : October 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. The difference between AUCs for PET/CT scan and scintigraphy [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01322256

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Centre Hospitalier Universitaire de Nîmes
Nîmes Cedex 09, Gard, France, 30029
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau du Roi, France, 30240
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
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Study Director: Sophie Schuldiner, MD Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Nathalie Jourdan, MD Centre Hospitalier Universitaire de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes Identifier: NCT01322256    
Other Study ID Numbers: AOI/2009/SJ-01
2010-020160-38 ( Other Identifier: RCB number )
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Diabetic Foot
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies