Status:
COMPLETED
Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis
Lead Sponsor:
ZetrOZ, Inc.
Conditions:
Osteo Arthritis Knee
Arthritis
Eligibility:
All Genders
45-85 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to measure the effectiveness of Sustained Acoustic Medicine (SAM) treatment combined with diclofenac ultrasound coupling gel in patients with stage II and stage III knee o...
Detailed Description
This is a seven day study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee osteoarthritis. ...
Eligibility Criteria
Inclusion
- Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
- Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
- 45-85 years of age
- Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding enrollment
- Report that knee pain negatively affects quality of life
- Willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound 1% diclofenac gel provided to the subject at the initiation of the study
- Deemed appropriate by their physician or by the study site physician to participate
Exclusion
- Cannot successfully demonstrate the ability to put on and take off the device
- Display any condition which, in the judgment of the investigator, would make participation in the study unacceptable, including, but not limited to, the subject's ability to understand and follow instructions.
- Have severe OA or have little to no cartilage in the knee
- Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
- Are non-ambulatory
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
- Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
- Currently taking steroids
- Have contraindication to radiograph
- Have a secondary cause of arthritis (metabolic or inflammatory)
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04391842
Start Date
September 1 2019
End Date
December 31 2019
Last Update
June 27 2023
Active Locations (1)
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1
Cayuga Medical Center -
Dryden, New York, United States, 13053