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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01322256
First received: March 23, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention
Diabetic Foot
Osteoarthritis
Procedure: Bone scintigraphy
Procedure: Leukoscan
Procedure: PET / CT
Procedure: Bone biopsy
Biological: Bloodwork

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • The difference between AUCs for PET/CT scan and scintigraphy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 109
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322256

Contacts
Contact: Sophie M Schuldiner, MD +33.(0)4.66.02.25.26 sophie.schuldiner@chu-nimes.fr
Contact: Carey M Suehs, PhD 33466686788 carey.suehs@chu-nimes.fr

Locations
France
Centre Hospitalier Universitaire de Nîmes Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Nathalie Jourdan, MD         
Sub-Investigator: Sophie Schuldiner, MD         
Sub-Investigator: Albert Sotto, MD PhD         
Sub-Investigator: Jean Philippe Lavigne, MD PhD         
Sub-Investigator: Dominique Blin, MD         
Sub-Investigator: Laurent Collombier, MD         
Sub-Investigator: Romain Bidar, MD         
Sub-Investigator: Pascal Roger, MD         
Sub-Investigator: Nicolas Cellier, MD         
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi Recruiting
Le Grau du Roi, France, 30240
Sub-Investigator: Sophie Schuldiner, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01322256     History of Changes
Other Study ID Numbers: AOI/2009/SJ-01, 2010-020160-38
Study First Received: March 23, 2011
Last Updated: March 4, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Osteoarthritis
Diabetic Foot
Arthritis
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
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 11, 2014