Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture

NCT05883241 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: BF-01-2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline

  Change in the self-described pain units on a scale by patient at baseline and post-treatment.

  Through study completion, average of 12 weeks.

Study Arms (1)

SAM Ultrasound Device and Diclofenac Patch

EXPERIMENTAL

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.

Device: Sustained Acoustic Device with 2.5% Diclofenac Patch; Drug: 2.5% Diclofenac Patches

Interventions

Sustained Acoustic Device with 2.5% Diclofenac Patch DEVICE

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.

Also known as: ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device Wearable, Long Duration Low-Intensity Device

SAM Ultrasound Device and Diclofenac Patch

2.5% Diclofenac Patches DRUG

Topical pain relief-gel worn during treatment via SAM patch.

SAM Ultrasound Device and Diclofenac Patch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZetrOZ, Inc.: lead

Study Sites (2)

ZetrOZ Systems LLC

Trumbull, Connecticut, 06611, United States

RECRUITING

National Sports Medicine Institute

Lansdowne, Virginia, 20176, United States

RECRUITING

Related Links

• Class II Medical Device

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• George K. Lewis, Ph.D.

  ZetrOZ Systems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George K. Lewis, Ph.D.

CONTACT

8882029831; george@zetroz.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 28, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)