Detection of Osteomyelitis Using High Resolution Ultrasound (NCT02198755) | Clinical Trial Compass
UnknownNot Applicable
Detection of Osteomyelitis Using High Resolution Ultrasound
United States100 participantsStarted 2014-12
Plain-language 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.
Who can participate
Age range18 Years ā 85 Years
SexALL
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Inclusion criteria
ā. Patient may be of any race and between 18-85 years of age.
ā. Patient has a current diagnosis of a chronic ulcer with suspected osteomyelitis.
ā. Patient's ulcer may be due to any etiology including but not limited to diabetes, trauma, neuropathic, pressure, venous, arterial, and inflammatory.
ā. 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.
ā. Patient's ulcer is suspected of causing a bone infection.
ā. Patient's ulcer may be of any size.
ā. Patient's wound may present with non-viable tissue.
ā. Patient circulation to the wound should be evaluated and treated using normal protocol.
Exclusion criteria
ā. Subject has a condition where an MRI is contraindicated
ā. In subjects where gadolinium enhancement MRI is planned then the following exclusion criteria apply:
ā. Patient must not be pregnant.
ā. Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
ā
What they're measuring
1
Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy