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

PHASE1RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

February 1, 2026

Study Completion Date

February 28, 2026

Conditions
Bone FractureFresh Fracture
Interventions
DEVICE

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.

DRUG

2.5% Diclofenac Patches

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

Trial Locations (2)

20176

RECRUITING

National Sports Medicine Institute, Lansdowne

06611

RECRUITING

ZetrOZ Systems LLC, Trumbull

All Listed Sponsors
lead

ZetrOZ, Inc.

INDUSTRY