This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting
Phase 2

Sustained Acoustic Medicine

Sponsor:

ZetrOZ, Inc.

Code:

NCT06257537

Conditions

Osteo Arthritis Knee

Arthritis

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Sustained Acoustic Device with 2.5% Diclofenac Patch

Sustained Acoustic Device with 0% Diclofenac Patch

2.5% Diclofenac Patches

SAM Patch

Study Details

Brief summary:

The purpose of this study is to assess the ability of long-duration low intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over a 24-week period.

The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain.

Secondary objectives are to assess the ability of LITUS to improve joint function.

Conditions

Osteo Arthritis Knee

Arthritis

Study ID

NCT06257537

Start date

Oct 1, 2024

Status verified date

Jun, 2026

Completion date

Jun 26, 2026

Primary completion date

Jun 26, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)
  • Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
  • Are between 50-85 years of age
  • Report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment
  • Report that knee pain negatively affects quality of life
  • Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
  • Are deemed appropriate by their physician or by the study site physician to participate.
  • Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.
  • Not use or initiate use of opioid and/or non-opioid analgesic medications.
  • Be willing to discontinue any other interventional treatment modalities on the knee during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).

Exclusion Criteria:

  • Cannot successfully demonstrate the ability to put on and take off the device.
  • Displays 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.
  • Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
  • Is pregnant.
  • Is a prisoner.
  • Is non-ambulatory (unable to walk).
  • Has a pacemaker.
  • Has a malignancy in the treatment area.
  • Has an active infection, open sores, or wounds in the treatment area.
  • Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.
  • Has a known neuropathy (disease of the brain or spinal nerves).
  • Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
  • Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months.
  • Are currently taking steroids.
  • Have any contraindication to radiograph.
  • Have a secondary cause of arthritis (metabolic or inflammatory).

Study Design

Enrollment

307 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAM Ultrasound Device and Diclofenac Patch

Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 24 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3 megahertz(MHz) frequency and 0.132 watts/cm\^2 intensity.

active comparator: SAM Ultrasound Device and SAM Patch

Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 24 weeks combined with SAM patch (0% diclofenac).

active comparator: Diclofenac Patch

Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 24 weeks combined.

placebo comparator: SAM Patch

Patients wear 0% diclofenac patch for 4 hours at least 5 days a week for 24 weeks combined.

Interventions

Sustained Acoustic Device with 2.5% Diclofenac Patch

Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm\^2 with 2.5% Diclofenac patches.

Sustained Acoustic Device with 0% Diclofenac Patch

Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.

2.5% Diclofenac Patches

Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.

SAM Patch

Ultrasound gel without additional pain relief medication worn for 4 hours at least 5 days a week via SAM patch.

Primary outcome measure

  • Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline [ Time Frame: Through study completion, average of 24 weeks. ]
  • Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Through study completion, average of 24 weeks. ]

Central Contacts and Locations

More Information

Sponsor

ZetrOZ, Inc.

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Low-Intensity Ultrasound
  • Drug Delivery
  • Sonophoresis
  • Transdermal Drug Delivery
  • Non-Steroidal Anti-Inflammatory Drugs
  • Sustained Acoustic Medication
  • Low-Intensity Continuous Ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by ZetrOZ, Inc. on 2026-06-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.