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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 month
Awards & highlights
Waltz Trial 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.Check my eligibility
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.See study design
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.
Waltz Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
Select...
I have been diagnosed with peripheral artery disease (PAD).
Waltz Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ankle Brachial Index
Mean acute flow rate difference during TUS treatment sessions
Tissue oxygen saturation (StO2)
Secondary outcome measures
Safety Endpoint
Waltz Trial Design
1Treatment groups
Experimental Treatment
Group I: TUS TherapyExperimental Treatment1 Intervention
These subjects will undergo treatments with the Vibrato Sleeve TUS device.
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Who is running the clinical trial?
Vibrato Medical, Inc.Lead Sponsor
3 Previous Clinical Trials
54 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
54 Patients Enrolled for Peripheral Arterial Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 years old or older.I have had a sudden loss of blood flow to a limb within the last 30 days.I have been diagnosed with peripheral artery disease (PAD).I have no ulcers or skin issues on the back of my lower leg.I have had a deep vein clot in my leg below the knee.I have not had any blood vessel surgery in the last 30 days.You have had a stent placed in your posterior tibial artery before.I have a severe long-term problem with my veins.I experience leg pain from walking but can walk without assistance.
Research Study Groups:
This trial has the following groups:- Group 1: TUS Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research program open for enrollment currently?
"Affirmative. The clinicaltrials.gov website shows that the trial was initially posted on February 22nd 2023 and later updated on May 24th of the same year. Currently, 12 participants are being sought from a single site."
Answered by AI
What is the cap for participants in this experiment?
"Affirmative. Verified by clinicaltrials.gov, the enrollment process for this medical trial is currently underway; it was posted on February 22nd of 2023 and last edited May 24th 2023. 12 volunteers need to be recruited from 1 facility."
Answered by AI
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