Recruiting
Phase 1

Sustained Acoustic Medicine

Sponsor:

ZetrOZ, Inc.

Code:

NCT05883241

Conditions

Bone Fracture

Fresh Fracture

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Sustained Acoustic Device with 2.5% Diclofenac Patch

2.5% Diclofenac Patches

Study Details

Brief summary:

The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period.

The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain.

Secondary objectives are to assess the ability of LITUS to improve patients return to work time.

Conditions

Bone Fracture

Fresh Fracture

Study ID

NCT05883241

Start date

Jun 1, 2023

Status verified date

Feb, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Have physician-diagnosed bone fracture
  • Are between 18-80 years of age
  • Report a pain score between 3-7 (range: 0-10) prior to enrolment
  • Report that pain from fracture 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 treatment 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 opioid and/or non-opioid analgesic medications.
  • Be willing to discontinue any other interventional treatment modalities on the affected area 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).
  • Are currently taking steroids.

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

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 12 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.

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.

2.5% Diclofenac Patches

Topical pain relief-gel worn during treatment 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 12 weeks. ]

Central Contacts and Locations

Central contacts

George K. Lewis, Ph.D.

8882029831george@zetroz.com

Locations

ZetrOZ Systems LLC

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

George K. Lewis, Ph.D.

18882029831george@zetroz.com

National Sports Medicine Institute

Recruiting

Lansdowne, Virginia, United States, 20176

Contacts

Timothy Johnson, MD

7037295010tjohnson@nationalsportsmed.com

More Information

Sponsor

ZetrOZ, Inc.

Last update posted

Feb 28, 2025

Last verified

Feb, 2025

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 2026-09-10. This information was provided to ClinicalTrials.gov by ZetrOZ, Inc. on 2025-02-28.