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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01322256
Acronym
ISEOD
Enrollment
12
Registered
2011-03-24
Start date
2012-10-31
Completion date
2014-10-31
Last updated
2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot, Osteoarthritis

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.

Interventions

Bone scintigraphy of the affected area

PROCEDURELeukoscan

Scintigraphy with labeled neutrophils

PROCEDUREPET / CT

PET / CT of the affected area

PROCEDUREBone biopsy

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

BIOLOGICALBloodwork

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
The difference between AUCs for PET/CT scan and scintigraphy1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026