<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02198755</url>
  </required_header>
  <id_info>
    <org_study_id>100-Osteo-HRUS-0601</org_study_id>
    <nct_id>NCT02198755</nct_id>
  </id_info>
  <brief_title>Detection of Osteomyelitis Using High Resolution Ultrasound</brief_title>
  <official_title>Sensitivity, Specificity and Predictive Value of High Resolution (B-Mode) Ultrasonography (HRUS) for the Detection of Osteomyelitis in Chronic Wound Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Calvary Hospital, Bronx, NY</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Calvary Hospital, Bronx, NY</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to establish the sensitivity of HRUS as compared to MRI for the&#xD;
      diagnosis of osteomyelitis in chronic wound patients; and to determine the specificity of&#xD;
      HRUS as compared to pathologic and microbiologic studies of bone biopsy tissues.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy</measure>
    <time_frame>at 3 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Osteomyelitis</condition>
  <arm_group>
    <arm_group_label>High Resolution Ultrasound</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High Resolution Ultrasonography (HRUS) with a Hitachi-Aloka Noblus Scanner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Magnetic Resonance Imaging (MRI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Magnetic Resonance Imaging (MRI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hitachi-Aloka Noblus ultrasound scanner</intervention_name>
    <description>High resolution ultrasound with the Hitachi-Aloka Noblus Scanner and a 8-15mHz transducer</description>
    <arm_group_label>High Resolution Ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>MRI with or without contrast</description>
    <arm_group_label>Magnetic Resonance Imaging (MRI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient may be of any race and between 18-85 years of age.&#xD;
&#xD;
          2. Patient has a current diagnosis of a chronic ulcer with suspected osteomyelitis.&#xD;
&#xD;
          3. Patient's ulcer may be due to any etiology including but not limited to diabetes,&#xD;
             trauma, neuropathic, pressure, venous, arterial, and inflammatory.&#xD;
&#xD;
          4. Patient's ulcer may extend through the dermis and into subcutaneous tissue&#xD;
             (granulation tissue may be present), and may include exposure of muscle, tendon, bone,&#xD;
             or joint capsule.&#xD;
&#xD;
          5. Patient's ulcer is suspected of causing a bone infection.&#xD;
&#xD;
          6. Patient's ulcer may be of any size.&#xD;
&#xD;
          7. Patient's wound may present with non-viable tissue.&#xD;
&#xD;
          8. Patient circulation to the wound should be evaluated and treated using normal&#xD;
             protocol.&#xD;
&#xD;
          9. Patient's diabetes is under control as determined by the Investigator. Patients must&#xD;
             have an HbA1c value less than 13.0%. Those patients whose glucose level is not deemed&#xD;
             to be in control should be referred to their primary physician for treatment of the&#xD;
             hyperglycemia.&#xD;
&#xD;
         10. Patient and caregiver are willing to participate in the clinical study and comply with&#xD;
             the follow-up regimen.&#xD;
&#xD;
         11. Patient or his/her legal representative has read and signed the Institutional Review&#xD;
             Board (IRB) approved Informed Consent form before treatment.&#xD;
&#xD;
         12. If patient is capable of childbirth, she is using medically accepted means of birth&#xD;
             control, and she tests negative on a serum pregnancy test.&#xD;
&#xD;
         13. Active localized acute wound infection or cellulitis: Subject may be considered for&#xD;
             study enrollment after the signs and symptoms of acute infection have resolved.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a condition where an MRI is contraindicated&#xD;
&#xD;
               -  Metallic fragments, clips or devices in the brain, eye, spinal canal, etc.:&#xD;
                  (Plain radiography is sufficient for screening&#xD;
&#xD;
               -  Magnetically activated implanted devices:&#xD;
&#xD;
             Cardiac pacemakers, insulin pumps, neuro¬stim¬u¬lators, cochlear implants, etc. may be&#xD;
             de-programmed.&#xD;
&#xD;
               -  Non-graphite spinal cord tongs: Graphite tongs are compatible.&#xD;
&#xD;
               -  Thermodilution Swan-Ganz catheter: Local heating can result. If unenhanced MRI is&#xD;
                  likely to provide sufficient information, gadolinium should not be administered&#xD;
                  to these patients. If, after review of clinical indications, gadolinium&#xD;
                  enhancement is judged to be important for diagnosis, the lowest effective dose of&#xD;
                  contrast agent should be used.&#xD;
&#xD;
          2. In subjects where gadolinium enhancement MRI is planned then the following exclusion&#xD;
             criteria apply:&#xD;
&#xD;
               -  Subject is allergic to contrast materials or cannot tolerate gadolinium&#xD;
&#xD;
               -  Subject is at risk of nephrogenic systemic fibrosis (NSF) or has severe renal&#xD;
                  failure (as determined by the investigator)&#xD;
&#xD;
          3. Patient must not be pregnant.&#xD;
&#xD;
          4. Patient has any condition(s) that seriously compromises the patient's ability to&#xD;
             complete this study.&#xD;
&#xD;
          5. Patient with recent surgical debridement of the bone in and around the ulcer site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oscar M Alvarez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director, Wound Care Center, Calvary Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Wendelken, DPM, RN</last_name>
    <role>Study Director</role>
    <affiliation>Staff Podiatrist, Wound Care Center, Calvary Hospital, Bronx, NY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Curative and Palliative Wound Care, Calvary Hospital</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Tashara Smith, BS</last_name>
      <phone>718-518-2577</phone>
      <email>tsmith@calvaryhospital.org</email>
    </contact>
    <investigator>
      <last_name>Martin Wendeken, DPM, RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Oscar M Alvarez, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lee Markowitz, DPM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Calvary Hospital, Bronx, NY</investigator_affiliation>
    <investigator_full_name>Oscar M. Alvarez, PhD</investigator_full_name>
    <investigator_title>Director, Center for Curative and Palliative Wound Care</investigator_title>
  </responsible_party>
  <keyword>high resolution ultrasound</keyword>
  <keyword>osteomyelitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteomyelitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02198755
org study id: 100-Osteo-HRUS-0601
nct id: NCT02198755
lead sponsor: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy
time frame: at 3 weeks
arm group label: High Resolution Ultrasound
arm group type: Active Comparator
description: High Resolution Ultrasonography (HRUS) with a Hitachi-Aloka Noblus Scanner
arm group label: Magnetic Resonance Imaging (MRI)
arm group type: Active Comparator
description: Magnetic Resonance Imaging (MRI)
intervention type: Device
intervention name: Hitachi-Aloka Noblus ultrasound scanner
description: High resolution ultrasound with the Hitachi-Aloka Noblus Scanner and a 8-15mHz transducer
arm group label: High Resolution Ultrasound
intervention type: Device
intervention name: Magnetic Resonance Imaging (MRI)
description: MRI with or without contrast
arm group label: Magnetic Resonance Imaging (MRI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Oscar M Alvarez, PhD
role: Principal Investigator
affiliation: Director, Wound Care Center, Calvary Hospital
last name: Martin Wendelken, DPM, RN
role: Study Director
affiliation: Staff Podiatrist, Wound Care Center, Calvary Hospital, Bronx, NY
facility: 
contact: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Calvary Hospital, Bronx, NY
investigator full name: Oscar M. Alvarez, PhD
investigator title: Director, Center for Curative and Palliative Wound Care
mesh term: Osteomyelitis