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Therapeutic Ultrasound

Therapeutic Ultrasound for Peripheral Arterial Disease (Waltz Trial)

N/A
Recruiting
Research Sponsored by Vibrato Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 65
Diagnosis of PAD
Must not have
Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf)
History or diagnosis of deep venous thrombosis below the knee in treatment leg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 month
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a ultrasound device can help PAD patients 65+ with leg symptoms.

Who is the study for?
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.
What is being tested?
The study is testing a device called VibratoSleeve Therapeutic Ultrasound to see if it can improve blood flow and reduce symptoms in patients with PAD. Participants will use this non-invasive device to determine its effectiveness and feasibility as a treatment option.
What are the potential side effects?
While specific side effects are not detailed here, therapeutic ultrasound may cause discomfort at the site of application. There could also be risks associated with increased blood flow in individuals with vascular conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
Select...
I have been diagnosed with peripheral artery disease (PAD).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have no ulcers or skin issues on the back of my lower leg.
Select...
I have had a deep vein clot in my leg below the knee.
Select...
I have not had any blood vessel surgery in the last 30 days.
Select...
I have a severe long-term problem with my veins.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ankle Brachial Index
Mean acute flow rate difference during TUS treatment sessions
Tissue oxygen saturation (StO2)
Secondary study objectives
Safety Endpoint

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TUS TherapyExperimental Treatment1 Intervention
These subjects will undergo treatments with the Vibrato Sleeve TUS device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VibratoSleeve Therapeutic Ultrasound Device
2023
N/A
~20

Find a Location

Who is running the clinical trial?

Vibrato Medical, Inc.Lead Sponsor
3 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

VibratoSleeve Therapeutic Ultrasound Device (Therapeutic Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT05888740 — N/A
Peripheral Artery Disease Research Study Groups: TUS Therapy
Peripheral Artery Disease Clinical Trial 2023: VibratoSleeve Therapeutic Ultrasound Device Highlights & Side Effects. Trial Name: NCT05888740 — N/A
VibratoSleeve Therapeutic Ultrasound Device (Therapeutic Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05888740 — N/A
~0 spots leftby Dec 2024
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