Detection of Osteomyelitis Using High Resolution Ultrasound

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.