Detection of Osteomyelitis Using High Resolution Ultrasound

NCT02198755 | Unknown

• 1 other identifier: 100-Osteo-HRUS-0601
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Osteomyelitis

Keywords

high resolution ultrasound; osteomyelitis

Outcome Measures

Primary Outcomes (1)

• Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy

  at 3 weeks

Study Arms (2)

High Resolution Ultrasound

ACTIVE COMPARATOR

High Resolution Ultrasonography (HRUS) with a Hitachi-Aloka Noblus Scanner

Device: Hitachi-Aloka Noblus ultrasound scanner

Magnetic Resonance Imaging (MRI)

ACTIVE COMPARATOR

Magnetic Resonance Imaging (MRI)

Device: Magnetic Resonance Imaging (MRI)

Interventions

Hitachi-Aloka Noblus ultrasound scanner DEVICE

High resolution ultrasound with the Hitachi-Aloka Noblus Scanner and a 8-15mHz transducer

High Resolution Ultrasound

Magnetic Resonance Imaging (MRI) DEVICE

MRI with or without contrast

Magnetic Resonance Imaging (MRI)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Calvary Hospital, Bronx, NY: lead

Study Sites (1)

Center for Curative and Palliative Wound Care, Calvary Hospital

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Osteomyelitis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Oscar M Alvarez, PhD

  Director, Wound Care Center, Calvary Hospital

  PRINCIPAL INVESTIGATOR

• Martin Wendelken, DPM, RN

  Staff Podiatrist, Wound Care Center, Calvary Hospital, Bronx, NY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Curative and Palliative Wound Care

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 24, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

US (1)