Detection of Osteomyelitis Using High Resolution Ultrasound

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Osteomyelitis
• Intervention / Treatment: Device: Hitachi-Aloka Noblus ultrasound scanner; Device: Magnetic Resonance Imaging (MRI)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Center for Curative and Palliative wound Care, Calvary Hospital
      • Contact: Tashara Smith, BS; Phone Number: 718-518-2577; Email: tsmith@calvaryhospital.org
      • Sub-Investigator: Martin Wendeken, DPM, RN
      • Principal Investigator: Oscar M Alvarez, PhD
      • Sub-Investigator: Lee Markowitz, DPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)	Device: Magnetic Resonance Imaging (MRI); MRI with or without contrast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy	at 3 weeks

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 24, 2014

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: osteomyelitis; high resolution ultrasound
• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Osteomyelitis
• Other Study ID Numbers: 100-Osteo-HRUS-0601