COMPLETED

Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)

Conditions

Peripheral Arterial Disease Therapeutic Ultrasound (TUS)Peripheral Artery Disease (PAD)Critical Limb Ischemia (CLI)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.

Official Title

A Prospective, Non-significant Risk, Feasibility Study to Evaluate Serial Applications of VibratoSleeve Therapy to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD) Subjects 65 Years of Age and Older

Quick Facts

Study Start:2023-02-22

Study Completion:2024-10-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05888740

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 65 2. Diagnosis of PAD. 3. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator.	1. Prior stenting in posterior tibial artery. 2. Re-vascularization procedure within 30 days prior to enrollment in the study. 3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf). 4. History or diagnosis of severe chronic venous insufficiency. 5. Acute limb ischemia within 30 days prior to treatment. 6. History or diagnosis of deep venous thrombosis below the knee in treatment leg. 7. Any conditions that, in the opinion of the investigator, may render the subject unable to complete the study or lead to difficulties for subject compliance with study requirements, or could confound study data. 8. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period.

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 65
2. Diagnosis of PAD.
3. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator.

1. Prior stenting in posterior tibial artery.
2. Re-vascularization procedure within 30 days prior to enrollment in the study.
3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
4. History or diagnosis of severe chronic venous insufficiency.
5. Acute limb ischemia within 30 days prior to treatment.
6. History or diagnosis of deep venous thrombosis below the knee in treatment leg.
7. Any conditions that, in the opinion of the investigator, may render the subject unable to complete the study or lead to difficulties for subject compliance with study requirements, or could confound study data.
8. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period.

Contacts and Locations

Study Locations (Sites)

Vascular & Interventional Specialists of Orange County

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: Vibrato Medical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-22

Study Completion Date2024-10-10

Study Record Updates

Study Start Date2023-02-22

Study Completion Date2024-10-10

Terms related to this study

Keywords Provided by Researchers

Therapeutic Ultrasound (TUS)
Peripheral Artery Disease (PAD)
Critical Limb Ischemia (CLI)

Additional Relevant MeSH Terms

Peripheral Arterial Disease