Diabetic FootISEODNCT01322256
PET/CT Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot
A study testing Bone scintigraphy, Leukoscan and PET / CT in people with Diabetic Foot and Osteoarthritis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Osteoarthritis
- What is being tested?
- Bone scintigraphy, Leukoscan and PET / CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau-du-Roi, 30240
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, 30029
About this study
Official title: Positron Emission Tomography - Computed Tomography (PET/CT) Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot
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.
- Conditions
- Diabetic Foot, Osteoarthritis
- Being tested
- Bone scintigraphy, Leukoscan, PET / CT, Bone biopsy, Bloodwork
- Medical subject headings
- Diabetic Foot, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone scintigraphyProcedure or surgery
Bone scintigraphy of the affected area
LeukoscanProcedure or surgery
Scintigraphy with labeled neutrophils
PET / CTProcedure or surgery
PET / CT of the affected area
Bone biopsyProcedure or surgery
A bone biopsy is performed during pre-inclusion work up.
BloodworkBiological
CRP and procalcitonin are measured in the pre-inclusion work up.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Bone scintigraphy; Procedure: Leukoscan; Procedure: PET / CT; Procedure: Bone biopsy; Biological: Bloodwork |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between AUCs for PET/CT scan and scintigraphy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startOct 2012
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: The study has proven to be infeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Schuldiner, MD, Study director, Centre Hospitalier Universitaire de NīmesNathalie Jourdan, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322256
- Sponsor's protocol ID
- AOI/2009/SJ-01
- Other IDs
- 2010-020160-38
- Acronym
- ISEOD
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2011
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography - Computed Tomography (PET/CT) Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot
- ClinicalTrials.gov ID
- NCT01322256
- Acronym / sponsor ID
- ISEOD / AOI/2009/SJ-01
- Conditions
- Diabetic Foot, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has proven to be infeasible.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | Experimental | Procedure: Bone scintigraphy, Procedure: Leukoscan, Procedure: PET / CT, Procedure: Bone biopsy, Biological: BloodworkPatients included in the study according to stated inclusion and exclusion criteria Intervention: Bone scintigraphy Intervention: Leukoscan Intervention: PET / CT Intervention: Bone biopsy Intervention: Bloodwork |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone scintigraphyBone scintigraphy of the affected area | Procedure or surgery | Included patients |
| LeukoscanScintigraphy with labeled neutrophils | Procedure or surgery | Included patients |
| PET / CTPET / CT of the affected area | Procedure or surgery | Included patients |
| Bone biopsyA bone biopsy is performed during pre-inclusion work up. | Procedure or surgery | Included patients |
| BloodworkCRP and procalcitonin are measured in the pre-inclusion work up. | Biological | Included patients |
Primary outcome
The difference between AUCs for PET/CT scan and scintigraphy
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The study has proven to be infeasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Schuldiner, MD study director
Centre Hospitalier Universitaire de Nīmes
Nathalie Jourdan, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone scintigraphy, Leukoscan and PET / CT in people with Diabetic Foot and Osteoarthritis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study has proven to be infeasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between AUCs for PET/CT scan and scintigraphy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.