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

NCT04391842 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: HF-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteo Arthritis Knee; Arthritis

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 on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.

  7 days

Secondary Outcomes (1)

• Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores, Ranging From 0 Being No Difficulty to 2400 Being Extreme Difficulty, From Baseline

  7 days

Study Arms (1)

Experimental: SAM ultrasound and diclofenac patch

EXPERIMENTAL

Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Combination Product: Sustained Acoustic Device with 1% Diclofenac patch

Interventions

Sustained Acoustic Device with 1% Diclofenac patch COMBINATION_PRODUCT

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

Experimental: SAM ultrasound and diclofenac patch

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
• Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
• years of age
• Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding enrollment
• Report that knee pain negatively affects quality of life
• Willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound 1% diclofenac gel provided to the subject at the initiation of the study
• Deemed appropriate by their physician or by the study site physician to participate

You may not qualify if:

• Cannot successfully demonstrate the ability to put on and take off the device
• Display 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.
• Have severe OA or have little to no cartilage in the knee
• Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
• Are non-ambulatory
• Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
• Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
• Currently taking steroids
• Have contraindication to radiograph
• Have a secondary cause of arthritis (metabolic or inflammatory)

Sponsors & Collaborators

• ZetrOZ, Inc.: lead

Study Sites (1)

Cayuga Medical Center -

Dryden, New York, 13053, United States

Location

Related Publications (1)

• Madzia A, Agrawal C, Jarit P, Petterson S, Plancher K, Ortiz R. Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. Open Orthop J. 2020;14:176-185. doi: 10.2174/1874325002014010176. Epub 2020 Dec 18.

  PMID: 33408796 DERIVED

Related Links

• Class II Medical Device

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Dr. Ralph Ortiz
• Organization: Medical Pain Consultants

drortizmpc@gmail.com

(607) 844-9979

Study Officials

• Ralph Ortiz, DO

  Medical Pain Consultants

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: February 17, 2020
• First Posted: May 18, 2020
• Study Start: September 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 27, 2023
• Results First Posted: September 23, 2021

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)