Diabetic Foot InfectionPhase 2NCT01764919
[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
A Phase 2 study testing [124I]FIAU in people with Diabetic Foot Infection, run by BioMed Valley Discoveries, Inc at 3 sites in United States.
Trial summary
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Infection
- What is being tested?
- [124I]FIAU
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to Feb 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female patients >/= 18 years on the day of signing consent.
- A diagnosis of diabetes mellitus, type I or II, as evidenced either by HbA1c>6.5% or receipt of antidiabetic medication at time of enrollment.
- Ability to provide informed consent
- An inframalleolar ulcer of perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2 or 3. At the discretion of the Investigator, patients with PEDIS grade 4 infections may be included if they are sufficiently stable.
- For females of childbearing potential, a negative urine pregnancy test on the day of dosing.
- For females of childbearing potential, a willingness to use 2 methods of contraception for 30 days after receiving [124I]FIAU.
- Ability to return for all study assessments.
- Clinically euthyroid, or on stable thyroid replacement therapy.
Who cannot join
- Patients who ar unable to comply with study requirements.
- Indication, in the opinion of the principal Investigator for urgent surgery that would preclude the time needed for PET-CT scanning, or clinical instability that precludes PET-CT scanning.
- History of an inherited mitochondrial disorder (eg. Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis [NARP], myoneurogenic gastrointestinal encephalopathy [MNGIE], myocolonic epilepsy with ragged red fibers [MERFF] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS])
- Alanine aminotransferase (ALT)>5x Upper Limit of Normal (ULN) OR aspartate aminotransferase (AST) >5x ULN.
- Body mass that exceeds the rating of the CT table.
- Hypersensitivity to iodine.
- Pregnant or breast-feeding.
- Any condition that would put the patient at unreasonable risk in the opinion of the Investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The University of Arizona
Tucson, Arizona, 85724
About this study
Official title: Exploration of the Use of [124I]FIAU Positron Emission Tomography-Computed Tomography Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection.
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.
- Conditions
- Diabetic Foot Infection
- Being tested
- [124I]FIAU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[124I]FIAURadiation
A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning.
| Study group | Role | What they receive |
|---|---|---|
| [124I]FIAU | Experimental | Single intravenous injection of [124I]FIAU in patients with diabetic foot infection Receives: Radiation: [124I]FIAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection.
A bone biopsy was obtained through a noninfected area and submitted for histology and microbiologic culture. Cultures were also to be obtained by biopsy after debridement of the ulcer from a clean base. Subjects were dosed with [124I]FIAU. PET-CT scanning were performed. All PET, PET-CT, and CT images, both attenuation corrected and uncorrected, were to be evaluated centrally and independently. Results from the bone biopsies were not available to the central reader of the PET-CT images. The sensitivity and specificity of [124I]FIAU PET-CT scanning in detecting osteomyelitis was determined based on its correlation with bone biopsy, the truth standard.
Measured: 30 hours
Secondary outcomes (3)
Assess the Safety and Tolerability of [124I]FIAU
Safety will be monitored for all subjects for the duration of their study participation. Safety will be assessed by monitoring of adverse events,vital signs, physical exams, and clinical laboratory tests including CBC and serum chemistry.
Measured: 30 +/- 2 days
Compare the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning to Gadolinium-enhanced (GE) Magnetic Resonance Imaging (MRI) and Non-GE-MRI Scanning in Detecting Osteomyelitis in Patients With Diabetic Foot Infection
All PET-CT images will be evaluated centrally and independently by a single radiologist. Diagnosis of osteomyelitis based on PET-CT will be compared with MRI which is currently the test of choice to diagnose osteomyelitis in diabetic foot infection.
Measured: -2 to 72 hours post dose [124I]FIAU
Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI
Additional information on the extent and localization of infection will be compared to MRI.
Measured: -2 to 72 hours post dose [124I]FIAU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionFeb 2014
Why it stopped: No correlation between FIAU uptake and bone biopsy results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot InfectionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMed Valley Discoveries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764919
- Sponsor's protocol ID
- BVD003
- Status last verified
- Apr 2016
- First submitted
- 7 Jan 2013
- Last updated
- 8 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Use of [124I]FIAU Positron Emission Tomography-Computed Tomography Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection.
- ClinicalTrials.gov ID
- NCT01764919
- Acronym / sponsor ID
- BVD003
- Conditions
- Diabetic Foot Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No correlation between FIAU uptake and bone biopsy results.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- BioMed Valley Discoveries, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Posted 8 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [124I]FIAU | Experimental | Radiation: [124I]FIAUSingle intravenous injection of [124I]FIAU in patients with diabetic foot infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients >/= 18 years on the day of signing consent.
- A diagnosis of diabetes mellitus, type I or II, as evidenced either by HbA1c>6.5% or receipt of antidiabetic medication at time of enrollment.
- Ability to provide informed consent
- An inframalleolar ulcer of perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2 or 3. At the discretion of the Investigator, patients with PEDIS grade 4 infections may be included if they are sufficiently stable.
- For females of childbearing potential, a negative urine pregnancy test on the day of dosing.
Key exclusion criteria (8 listed)
- Patients who ar unable to comply with study requirements.
- Indication, in the opinion of the principal Investigator for urgent surgery that would preclude the time needed for PET-CT scanning, or clinical instability that precludes PET-CT scanning.
- History of an inherited mitochondrial disorder (eg. Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis [NARP], myoneurogenic gastrointestinal encephalopathy [MNGIE], myocolonic epilepsy with ragged red fibers [MERFF] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS])
- Alanine aminotransferase (ALT)>5x Upper Limit of Normal (ULN) OR aspartate aminotransferase (AST) >5x ULN.
- Body mass that exceeds the rating of the CT table.
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 |
|---|---|---|
| [124I]FIAUA single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning. | Radiation | [124I]FIAU |
Primary outcome
Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection.
Time frame: 30 hours
A bone biopsy was obtained through a noninfected area and submitted for histology and microbiologic culture. Cultures were also to be obtained by biopsy after debridement of the ulcer from a clean base. Subjects were dosed with [124I]FIAU. PET-CT scanning were performed. All PET, PET-CT, and CT images, both attenuation corrected and uncorrected, were to be evaluated centrally and independently. Results from the bone biopsies were not available to the central reader of the PET-CT images. The sensitivity and specificity of [124I]FIAU PET-CT scanning in detecting osteomyelitis was determined based on its correlation with bone biopsy, the truth standard.
3 secondary outcomes
Assess the Safety and Tolerability of [124I]FIAU
Time frame: 30 +/- 2 days
Compare the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning to Gadolinium-enhanced (GE) Magnetic Resonance Imaging (MRI) and Non-GE-MRI Scanning in Detecting Osteomyelitis in Patients With Diabetic Foot Infection
Time frame: -2 to 72 hours post dose [124I]FIAU
Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI
Time frame: -2 to 72 hours post dose [124I]FIAU
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [124I]FIAU in people with Diabetic Foot Infection, run by BioMed Valley Discoveries, Inc at 3 sites in United States.
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 8 inclusion and 8 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 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection. (time frame: 30 hours). 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 8 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.