Detection of Osteomyelitis Using High Resolution Ultrasound

Chronic Osteomyelitis Clinical Trial

Official title:

Sensitivity, Specificity and Predictive Value of High Resolution (B-Mode) Ultrasonography (HRUS) for the Detection of Osteomyelitis in Chronic Wound Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02198755
• Other study ID #: 100-Osteo-HRUS-0601
• Status: Not yet recruiting
• Phase: N/A
• First received: July 22, 2014
• Last updated: July 23, 2014
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2014
• Source: Calvary Hospital, Bronx, NY
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Osteomyelitis
• Osteomyelitis

Intervention

Device:
• Hitachi-Aloka Noblus ultrasound scanner
High resolution ultrasound with the Hitachi-Aloka Noblus Scanner and a 8-15mHz transducer
• Magnetic Resonance Imaging (MRI)
MRI with or without contrast

Locations

Country	Name	City	State
United States	Center for Curative and Palliative Wound Care, Calvary Hospital	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Calvary Hospital, Bronx, NY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy		at 3 weeks	No