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Detection of Osteomyelitis Using High Resolution Ultrasound

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ClinicalTrials.gov Identifier: NCT02198755
Recruitment Status : Unknown
Verified July 2014 by Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY.
Recruitment status was:  Not yet recruiting
First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Osteomyelitis Device: Hitachi-Aloka Noblus ultrasound scanner Device: Magnetic Resonance Imaging (MRI) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Sensitivity, Specificity and Predictive Value of High Resolution (B-Mode) Ultrasonography (HRUS) for the Detection of Osteomyelitis in Chronic Wound Patients
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High Resolution Ultrasound
High Resolution Ultrasonography (HRUS) with a Hitachi-Aloka Noblus Scanner
Device: Hitachi-Aloka Noblus ultrasound scanner
High resolution ultrasound with the Hitachi-Aloka Noblus Scanner and a 8-15mHz transducer

Active Comparator: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI)
Device: Magnetic Resonance Imaging (MRI)
MRI with or without contrast




Primary Outcome Measures :
  1. Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy [ Time Frame: at 3 weeks ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient may be of any race and between 18-85 years of age.
  2. Patient has a current diagnosis of a chronic ulcer with suspected osteomyelitis.
  3. Patient's ulcer may be due to any etiology including but not limited to diabetes, trauma, neuropathic, pressure, venous, arterial, and inflammatory.
  4. 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.
  5. Patient's ulcer is suspected of causing a bone infection.
  6. Patient's ulcer may be of any size.
  7. Patient's wound may present with non-viable tissue.
  8. Patient circulation to the wound should be evaluated and treated using normal protocol.
  9. 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.
  10. Patient and caregiver are willing to participate in the clinical study and comply with the follow-up regimen.
  11. Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment.
  12. If patient is capable of childbirth, she is using medically accepted means of birth control, and she tests negative on a serum pregnancy test.
  13. Active localized acute wound infection or cellulitis: Subject may be considered for study enrollment after the signs and symptoms of acute infection have resolved.

Exclusion Criteria:

  1. 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.
  2. 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)
  3. Patient must not be pregnant.
  4. Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
  5. Patient with recent surgical debridement of the bone in and around the ulcer site.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198755


Locations
United States, New York
Center for Curative and Palliative Wound Care, Calvary Hospital Not yet recruiting
Bronx, New York, United States, 10461
Contact: Tashara Smith, BS    718-518-2577    tsmith@calvaryhospital.org   
Sub-Investigator: Martin Wendeken, DPM, RN         
Principal Investigator: Oscar M Alvarez, PhD         
Sub-Investigator: Lee Markowitz, DPM         
Sponsors and Collaborators
Calvary Hospital, Bronx, NY
Investigators
Principal Investigator: Oscar M Alvarez, PhD Director, Wound Care Center, Calvary Hospital
Study Director: Martin Wendelken, DPM, RN Staff Podiatrist, Wound Care Center, Calvary Hospital, Bronx, NY

Responsible Party: Oscar M. Alvarez, PhD, Director, Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier: NCT02198755     History of Changes
Other Study ID Numbers: 100-Osteo-HRUS-0601
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY:
high resolution ultrasound
osteomyelitis

Additional relevant MeSH terms:
Osteomyelitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases