Acoustic Medicine for Circulation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new device called the Sustained Acoustic Medicine Device, which uses sound waves to improve blood flow. Participants will receive treatment on their forearms using the device, paired with either a diclofenac gel patch or a standard gel patch. The goal is to observe how these combinations affect circulation. Healthy individuals, particularly those without circulation issues in their arms, are encouraged to join.
As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the Sustained Acoustic Medicine Device is safe for circulation?
Research has shown that the Sustained Acoustic Medicine (SAM) device is generally safe. Users find it wearable, comfortable, and easy to use, making it popular among athletes and others outside clinical settings. The device has FDA clearance, indicating it meets U.S. safety standards for medical devices.
Studies also indicate that regular ultrasound treatments with devices like SAM can relieve pain and improve physical function without causing harm. Although specific details on side effects are not provided, these findings suggest the treatment is well-tolerated. As this trial is in its early stages, it primarily focuses on assessing safety. This indicates the treatment is considered safe enough for human testing, with more information to become available as the trial progresses.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they use the SAM Ultrasonic Diathermy Device, which emits continuous ultrasound at a 3-megahertz frequency and 0.132 watts/cm² intensity. This approach is different from standard treatments like medication or physical therapy for improving circulation. The ultrasound device, combined with either a standard gel or a diclofenac gel patch, aims to enhance blood flow and reduce inflammation directly at the site. Such localized, non-invasive treatment has the potential to quickly improve circulation and reduce pain, offering a novel alternative to existing methods.
What evidence suggests that the Sustained Acoustic Medicine Device is effective for improving circulation?
Research has shown that the Sustained Acoustic Medicine (SAM) device can significantly improve blood flow. One study demonstrated that SAM increased blood flow by 19.2 units (a measure of blood flow) in just 60 minutes. Another study found that SAM boosts local circulation and oxygen levels, accelerating healing and reducing pain. The device sends sound waves into the body, generating heat and movement that enhance blood flow. In this trial, participants will receive treatment with the SAM device in different arms, using either a diclofenac ultrasound gel patch or a standard ultrasound gel patch on the forearm. Overall, evidence suggests that SAM effectively increases local blood flow, potentially aiding circulation problems.678910
Who Is on the Research Team?
George K Lewis, PhD
Principal Investigator
ZetrOZ Systems LLC
Are You a Good Fit for This Trial?
This trial is for healthy volunteers who want to help test a device called Sustained Acoustic Medicine on blood circulation. People can't join if they have infections, open sores, or wounds where the device will be used, any issues with blood flow in their limbs, or if they are pregnant or nursing.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment from the SAM Ultrasonic Diathermy Device for 1 hour with either a diclofenac or standard ultrasound gel patch on the forearm
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sustained Acoustic Medicine Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
ZetrOZ, Inc.
Lead Sponsor