Chronic OsteomyelitisNCT02198755
Detection of Osteomyelitis Using High Resolution Ultrasound
A study testing Hitachi-Aloka Noblus ultrasound scanner and Magnetic Resonance Imaging (MRI) in people with Chronic Osteomyelitis, run by Calvary Hospital, Bronx, NY at 1 site in United States.
Trial summary
The purpose of this study is to establish the sensitivity of HRUS as compared to MRI for the diagnosis of osteomyelitis in chronic wound patients; and to determine the specificity of HRUS as compared to pathologic and microbiologic studies of bone biopsy tissues. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Osteomyelitis
- What is being tested?
- Hitachi-Aloka Noblus ultrasound scanner and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jun 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient may be of any race and between 18-85 years of age.
- Patient has a current diagnosis of a chronic ulcer with suspected osteomyelitis.
- Patient's ulcer may be due to any etiology including but not limited to diabetes, trauma, neuropathic, pressure, venous, arterial, and inflammatory.
- Patient's ulcer may extend through the dermis and into subcutaneous tissue (granulation tissue may be present), and may include exposure of muscle, tendon, bone, or joint capsule.
- Patient's ulcer is suspected of causing a bone infection.
- Patient's ulcer may be of any size.
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- Patient's wound may present with non-viable tissue.
- Patient circulation to the wound should be evaluated and treated using normal protocol.
- Patient's diabetes is under control as determined by the Investigator. Patients must have an HbA1c value less than 13.0%. Those patients whose glucose level is not deemed to be in control should be referred to their primary physician for treatment of the hyperglycemia.
- Patient and caregiver are willing to participate in the clinical study and comply with the follow-up regimen.
- Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment.
- If patient is capable of childbirth, she is using medically accepted means of birth control, and she tests negative on a serum pregnancy test.
- Active localized acute wound infection or cellulitis: Subject may be considered for study enrollment after the signs and symptoms of acute infection have resolved.
Who cannot join
- Subject has a condition where an MRI is contraindicated
- Metallic fragments, clips or devices in the brain, eye, spinal canal, etc.: (Plain radiography is sufficient for screening
- Magnetically activated implanted devices:
- Cardiac pacemakers, insulin pumps, neuro¬stim¬u¬lators, cochlear implants, etc. may be de-programmed.
- Non-graphite spinal cord tongs: Graphite tongs are compatible.
- Thermodilution Swan-Ganz catheter: Local heating can result. If unenhanced MRI is likely to provide sufficient information, gadolinium should not be administered to these patients. If, after review of clinical indications, gadolinium enhancement is judged to be important for diagnosis, the lowest effective dose of contrast agent should be used.
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- In subjects where gadolinium enhancement MRI is planned then the following exclusion criteria apply:
- Subject is allergic to contrast materials or cannot tolerate gadolinium
- Subject is at risk of nephrogenic systemic fibrosis (NSF) or has severe renal failure (as determined by the investigator)
- Patient must not be pregnant.
- Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
- Patient with recent surgical debridement of the bone in and around the ulcer site.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Curative and Palliative Wound Care, Calvary Hospital
The Bronx, New York, 10461
Tashara Smith, BS, 718-518-2577, tsmith@calvaryhospital.org
Martin Wendeken, DPM, RN
About this study
Official title: Sensitivity, Specificity and Predictive Value of High Resolution (B-Mode) Ultrasonography (HRUS) for the Detection of Osteomyelitis in Chronic Wound Patients
The purpose of this study is to establish the sensitivity of HRUS as compared to MRI for the diagnosis of osteomyelitis in chronic wound patients; and to determine the specificity of HRUS as compared to pathologic and microbiologic studies of bone biopsy tissues.
- Conditions
- Chronic Osteomyelitis
- Being tested
- Hitachi-Aloka Noblus ultrasound scanner, Magnetic Resonance Imaging (MRI)
- Keywords
- high resolution ultrasound, osteomyelitis
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hitachi-Aloka Noblus ultrasound scannerDevice
High resolution ultrasound with the Hitachi-Aloka Noblus Scanner and a 8-15mHz transducer
Magnetic Resonance Imaging (MRI)Device
MRI with or without contrast
| Study group | Role | What they receive |
|---|---|---|
| High Resolution Ultrasound | Active comparator | High Resolution Ultrasonography (HRUS) with a Hitachi-Aloka Noblus Scanner Receives: Device: Hitachi-Aloka Noblus ultrasound scanner |
| Magnetic Resonance Imaging (MRI) | Active comparator | Magnetic Resonance Imaging (MRI) Receives: Device: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy
Measured: at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic OsteomyelitisStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calvary Hospital, Bronx, NY
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
- Investigators
- Oscar M Alvarez, PhD, Principal investigator, Director, Wound Care Center, Calvary HospitalMartin Wendelken, DPM, RN, Study director, Staff Podiatrist, Wound Care Center, Calvary Hospital, Bronx, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198755
- Sponsor's protocol ID
- 100-Osteo-HRUS-0601
- Status last verified
- Jul 2014
- First submitted
- 22 Jul 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity, Specificity and Predictive Value of High Resolution (B-Mode) Ultrasonography (HRUS) for the Detection of Osteomyelitis in Chronic Wound Patients
- ClinicalTrials.gov ID
- NCT02198755
- Acronym / sponsor ID
- 100-Osteo-HRUS-0601
- Conditions
- Chronic Osteomyelitis
- Keywords
- high resolution ultrasound, osteomyelitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Calvary Hospital, Bronx, NYUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 24 Jul 2014 (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 purpose of this study is to establish the sensitivity of HRUS as compared to MRI for the diagnosis of osteomyelitis in chronic wound patients; and to determine the specificity of HRUS as compared to pathologic and microbiologic studies of bone biopsy tissues.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Resolution Ultrasound | Active comparator | Device: Hitachi-Aloka Noblus ultrasound scannerHigh Resolution Ultrasonography (HRUS) with a Hitachi-Aloka Noblus Scanner |
| Magnetic Resonance Imaging (MRI) | Active comparator | Device: Magnetic Resonance Imaging (MRI)Magnetic Resonance Imaging (MRI) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient may be of any race and between 18-85 years of age.
- Patient has a current diagnosis of a chronic ulcer with suspected osteomyelitis.
- Patient's ulcer may be due to any etiology including but not limited to diabetes, trauma, neuropathic, pressure, venous, arterial, and inflammatory.
- Patient's ulcer may extend through the dermis and into subcutaneous tissue (granulation tissue may be present), and may include exposure of muscle, tendon, bone, or joint capsule.
- Patient's ulcer is suspected of causing a bone infection.
Key exclusion criteria (12 listed)
- Subject has a condition where an MRI is contraindicated
- Cardiac pacemakers, insulin pumps, neuro¬stim¬u¬lators, cochlear implants, etc. may be de-programmed.
- In subjects where gadolinium enhancement MRI is planned then the following exclusion criteria apply:
- Patient must not be pregnant.
- Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
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 |
|---|---|---|
| Hitachi-Aloka Noblus ultrasound scannerHigh resolution ultrasound with the Hitachi-Aloka Noblus Scanner and a 8-15mHz transducer | Device | High Resolution Ultrasound |
| Magnetic Resonance Imaging (MRI)MRI with or without contrast | Device | Magnetic Resonance Imaging (MRI) |
Primary outcome
Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy
Time frame: at 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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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.
Center for Curative and Palliative Wound Care, Calvary Hospital
The Bronx, United States
Oscar M Alvarez, PhD principal investigator
Director, Wound Care Center, Calvary Hospital
Martin Wendelken, DPM, RN study director
Staff Podiatrist, Wound Care Center, Calvary Hospital, Bronx, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hitachi-Aloka Noblus ultrasound scanner and Magnetic Resonance Imaging (MRI) in people with Chronic Osteomyelitis, run by Calvary Hospital, Bronx, NY at 1 site 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 13 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy (time frame: at 3 weeks). 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 24 Jul 2014.