NCT01322256

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

March 23, 2011

Last Update Submit

March 24, 2015

Conditions

Diabetic FootOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • The difference between AUCs for PET/CT scan and scintigraphy

    1 year

Study Arms (1)

Included patients

EXPERIMENTAL

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 scintigraphyProcedure: LeukoscanProcedure: PET / CTProcedure: Bone biopsyBiological: Bloodwork

Interventions

Bone scintigraphyPROCEDURE

Bone scintigraphy of the affected area

Included patients
LeukoscanPROCEDURE

Scintigraphy with labeled neutrophils

Included patients
PET / CTPROCEDURE

PET / CT of the affected area

Included patients
Bone biopsyPROCEDURE

A bone biopsy is performed during pre-inclusion work up.

Included patients
BloodworkBIOLOGICAL

CRP and procalcitonin are measured in the pre-inclusion work up.

Included patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • The patient is participating in another 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
  • severe claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi

Le Grau-du-Roi, 30240, France

Location

MeSH Terms

Conditions

Diabetic FootOsteoarthritis

Interventions

Sulesomab2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Sophie Schuldiner, MD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

  • Nathalie Jourdan, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

FR(2)