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Device

Sustained Acoustic Device with 2.5% Diclofenac Patch for Osteoarthritis

Phase 1

Waitlist Available

Led By Sandra Winkler, 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, average of 8 weeks

Awards & highlights

Study Summary

This trial will compare two methods of treating symptoms of knee osteoarthritis: Sustained Acoustic Medicine (SAM) vs a topical pain relief gel. Pain and function scores will be measured to determine which method is more effective.

Eligible Conditions

Osteoarthritis of the Knee

Timeline

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 8 weeks for reporting.

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

Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: 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 II: Over the Counter Arthritis Pain GelActive Control1 Intervention

Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.

Group III: Placebo SAM Ultrasound Device and Diclofenac PatchPlacebo Group1 Intervention

Patients receive placebo treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 0% diclofenac patch.

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

Do I qualify?Apply below to find out

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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

1,235 Total Patients Enrolled

7 Trials studying Osteoarthritis

802 Patients Enrolled for Osteoarthritis

Sandra Winkler, Ph.D.Principal InvestigatorJames A. Haley Veterans Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over the age of fifty-five eligible to participate in this experiment?

"This clinical trial seeks patients aged 35 to 80. Participants younger than 18 have access to 38 other trials, and those older than 65 can choose from 656 studies."

Answered by AI

Is enrollment for this trial currently open?

"Affirmative. Per the details on clinicaltrials.gov, recruitment for this investigation is underway; it was launched on February 14th 2022 and subsequently updated the same day. The research team seeks 90 participants from 1 medical centre."

Answered by AI

What criteria must individuals meet to be considered for enrollment in this trial?

"This medical study seeks to enrol 90 patients suffering from arthrosis aged between 35 and 80. Prospective applicants must fulfil the following criteria: Have physician-diagnosed mild or moderate knee arthritis (OARSI atlas grades 1-2), Meet American College of Rheumatology's clinical and radiological diagnostic standards for knee OA, Report a frequent pain score between 3-7 during the week preceding entry, Demonstrate how their knee agony impairs quality of life, Be willing not to use any cream, gel or topical solution other than that provided at commencement of trial., Be deemed fit by a doctor to participate in this research"

Answered by AI

Has the Sustained Acoustic Device with 2.5% Diclofenac Patch been given regulatory clearance by the FDA?

"The safety of Sustained Acoustic Device with 2.5% Diclofenac Patch was rated a 1 according to our team's assessment at Power, as this is only Phase 1 trial and there are limited data verifying both its efficacy and security."

Answered by AI

What is the current enrollment level of this clinical experiment?

"Affirmative. The details uploaded to clinicaltrials.gov demonstrate that this medical trial, which was launched on February 14th 2022, is presently recruiting individuals for participation. 90 participants are sought from 1 distinct site."

Answered by AI