Therapeutic Ultrasound for Peripheral Arterial Disease
(Waltz Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the VibratoSleeve, which uses therapeutic ultrasound to help people with peripheral arterial disease (PAD) improve leg symptoms. The goal is to determine if this treatment can relieve pain or discomfort while walking, a common issue in PAD. Suitable participants have been diagnosed with PAD, are at least 65 years old, and experience moderate pain or cramping in their legs when walking. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance the quality of life for those with PAD.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this therapeutic ultrasound device is safe for peripheral arterial disease patients?
Research shows that the VibratoSleeve Therapeutic Ultrasound Device poses a low risk, meaning it is generally less likely to cause harm. Past studies found no major safety problems in patients using this device. As a non-invasive treatment, it does not involve surgery or entering the body, typically resulting in fewer side effects. The data provided includes no specific reports of serious unwanted effects related to this device. However, discussing any concerns with a healthcare professional before joining a trial is always advisable.12345
Why are researchers excited about this trial?
The VibratoSleeve Therapeutic Ultrasound Device is unique because it uses therapeutic ultrasound to improve blood flow in patients with Peripheral Arterial Disease (PAD). Unlike traditional treatments like medications, exercise, or surgical interventions, this device offers a non-invasive method that targets the affected arteries directly. Researchers are excited about its potential to enhance blood circulation without the need for surgery, reducing recovery time and possibly improving patient outcomes.
What evidence suggests that the VibratoSleeve Therapeutic Ultrasound Device is effective for peripheral arterial disease?
Research has shown that the VibratoSleeve Therapeutic Ultrasound Device, used by participants in this trial, may improve symptoms for people with peripheral arterial disease (PAD). Studies have found that the device can boost blood flow and oxygen levels in the legs, addressing common issues in PAD. One study highlighted improved blood supply to the feet. The device is easy to use because it is non-invasive and wearable, eliminating the need for surgery or a hospital stay. Early results suggest this device could be a useful tool for managing PAD symptoms.13467
Are You a Good Fit for This Trial?
This trial is for people aged 65 or older who have Peripheral Arterial Disease (PAD) and experience leg pain when walking, classified as Rutherford class 1,2, or 3. It's not suitable for those with severe venous issues, recent limb ischemia, stenting in the tibial artery, recent re-vascularization procedures, deep vein thrombosis below the knee in the treatment leg, skin problems in treatment areas or those participating in another study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TUS treatment with the VibratoSleeve device to assess acute vasodilatory and perfusion effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VibratoSleeve Therapeutic Ultrasound Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vibrato Medical, Inc.
Lead Sponsor