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Therapeutic Ultrasound
Therapeutic Ultrasound for Peripheral Arterial Disease
N/A
Waitlist Available
Research Sponsored by Vibrato Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights
Study Summary
This trial will test how well a device using ultrasound works on subjects to determine the most effective treatment. Subjects will receive treatment sessions over 45 days with follow-up visits afterwards.
Eligible Conditions
- Peripheral Arterial Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in foot perfusion
Secondary outcome measures
Adverse Events
Subject Questionnaire
Trial Design
1Treatment groups
Experimental Treatment
Group I: VibratoSleeve TUSExperimental Treatment1 Intervention
Subjects will receive 30 TUS treatments, each one lasting 90 minutes on the calf of a leg with peripheral arterial disease.
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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:- You have been diagnosed with a blockage in the arteries below the knee.You have had a stent placed in certain leg arteries before.You have ulcers, cellulitis, or skin breakdown on the back of your calf where the treatment would be applied.You have a history of serious problems with the veins in your legs.You have had a serious problem with blood flow to your limbs in the past month.If you have PAD in both legs, we will only treat the leg that is more severely affected.Your doctor has determined that you have severe peripheral artery disease (PAD) based on your symptoms.Your toe blood pressure is very low.If you had a re-vascularization procedure within 25 days before the study starts, you cannot participate. If the procedure was done earlier than 25 days before the study starts and you meet all other criteria, you can participate.You have a history of blood clots in the lower part of your leg that needed treatment.Your diabetes is not well controlled, with an HbA1c level higher than 10%.
Research Study Groups:
This trial has the following groups:- Group 1: VibratoSleeve TUS
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 there still capacity to enroll participants in this medical research?
"Based on the information presented through clinicaltrials.gov, this trial is no longer taking participants. It was first opened to recruitment on January 14th 2022 and last updated May 19th 2023. Despite not being currently recruiting, there are 220 other studies seeking patients at present."
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