NCT04391842

Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: ZetrOZ, Inc. · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to measure the effectiveness of Sustained Acoustic Medicine (SAM) treatment combined with diclofenac ultrasound coupling gel in patients with stage II and stage III knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase function of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.

Detailed description

This is a seven day study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee osteoarthritis. The class-II device, sam® has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 6 days, patients will self-apply the wearable SAM device with diclofenac patch to their affected knee for 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as 30 minutes, 2-hours and 4-hours after applying the device. A quality of life and function assessment will be performed prior to the patient beginning the protocol and at the conclusion of the protocol. Up to 32 subjects will be recruited from neighboring communities to the study sites. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals.

Conditions

• Osteo Arthritis Knee
• Arthritis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Sustained Acoustic Device with 1% Diclofenac patch	Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch Other Names: * ZetrOZ ultrasound device * wearable ultrasound device * long duration ultrasound * LITUS device * long duration low intensity device

Timeline

• Start date: 2019-09-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2020-05-18
• Last updated: 2023-06-27
• Results posted: 2021-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study