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Topical Gel
Sustained Acoustic Device with 2.5% Diclofenac Patch for Osteoarthritis
Phase 1 & 2
Waitlist Available
Led By George K Lewis, Ph.D.
Research Sponsored by ZetrOZ, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average of 8 weeks
Awards & highlights
Study Summary
This study is evaluating whether ultrasound devices and common pain relief gel are usable for people with arthritis.
Eligible Conditions
- Osteoarthritis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, average of 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average of 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Erythrocyte Indices
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SAM2 Ultrasound Device and Diclofenac PatchExperimental Treatment1 Intervention
Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Group II: SAM Ultrasound Device and Diclofenac PatchExperimental Treatment1 Intervention
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Group III: Topical Pain-Relief GelPlacebo Group1 Intervention
Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sustained Acoustic Device with 2.5% Diclofenac Patch
2022
Completed Phase 2
~290
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ZetrOZ, Inc.Lead Sponsor
15 Previous Clinical Trials
1,205 Total Patients Enrolled
7 Trials studying Osteoarthritis
772 Patients Enrolled for Osteoarthritis
George K Lewis, Ph.D.Principal InvestigatorZetrOZ Systems
2 Previous Clinical Trials
500 Total Patients Enrolled
2 Trials studying Osteoarthritis
500 Patients Enrolled for Osteoarthritis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
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