Back to resultsFeasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD) (Waltz)
Primary Purpose
Peripheral Arterial Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VibratoSleeve Therapeutic Ultrasound Device
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Therapeutic Ultrasound (TUS), Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI)
Eligibility Criteria
Inclusion Criteria: Age ≥ 65 Diagnosis of PAD. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator. Exclusion Criteria: Prior stenting in posterior tibial artery. Re-vascularization procedure within 30 days prior to enrollment in the study. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf). History or diagnosis of severe chronic venous insufficiency. Acute limb ischemia within 30 days prior to treatment. History or diagnosis of deep venous thrombosis below the knee in treatment leg. 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. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period. stenting in posterior tibial artery.
Sites / Locations
- Vascular & Interventional Specialists of Orange CountyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TUS Therapy
Arm Description
These subjects will undergo treatments with the Vibrato Sleeve TUS device.
Outcomes
Primary Outcome Measures
Mean acute flow rate difference during TUS treatment sessions
Quantify perfusion rate
Tissue oxygen saturation (StO2)
Assess oxygenation
Ankle Brachial Index
Ankle brachial indices to assess the difference in blood pressure in the upper arm and lower limbs
Secondary Outcome Measures
Safety Endpoint
Device and procedure related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05888740
Brief Title
Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)
Acronym
Waltz
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vibrato Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in subjects with early stage PAD. Each subject will receive TUS treatment multiple sessions. All post- treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Therapeutic Ultrasound (TUS), Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single arm, open-label, feasibility acute phase study
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TUS Therapy
Arm Type
Experimental
Arm Description
These subjects will undergo treatments with the Vibrato Sleeve TUS device.
Intervention Type
Device
Intervention Name(s)
VibratoSleeve Therapeutic Ultrasound Device
Intervention Description
The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf
Primary Outcome Measure Information:
Title
Mean acute flow rate difference during TUS treatment sessions
Description
Quantify perfusion rate
Time Frame
Through study completion, an average of 1 month
Title
Tissue oxygen saturation (StO2)
Description
Assess oxygenation
Time Frame
Through study completion, an average of 1 month
Title
Ankle Brachial Index
Description
Ankle brachial indices to assess the difference in blood pressure in the upper arm and lower limbs
Time Frame
Through study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
Safety Endpoint
Description
Device and procedure related adverse events
Time Frame
Through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 65
Diagnosis of PAD.
Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator.
Exclusion Criteria:
Prior stenting in posterior tibial artery.
Re-vascularization procedure within 30 days prior to enrollment in the study.
Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
History or diagnosis of severe chronic venous insufficiency.
Acute limb ischemia within 30 days prior to treatment.
History or diagnosis of deep venous thrombosis below the knee in treatment leg.
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.
Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period.
stenting in posterior tibial artery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bisrat Woldemichael
Phone
213-921-0588
Email
bisrat@vibratomedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana Elstad
Email
juliana@vibratomedical.com
Facility Information:
Facility Name
Vascular & Interventional Specialists of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Khalsa, MD
Phone
714-598-1194
Email
info@visoc.org
First Name & Middle Initial & Last Name & Degree
Raj Khalsa, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26062950
Citation
Nazer B, Ghahghaie F, Kashima R, Khokhlova T, Perez C, Crum L, Matula T, Hata A. Therapeutic Ultrasound Promotes Reperfusion and Angiogenesis in a Rat Model of Peripheral Arterial Disease. Circ J. 2015;79(9):2043-9. doi: 10.1253/circj.CJ-15-0366. Epub 2015 Jun 9.
Results Reference
result
Learn more about this trial
Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)
We'll reach out to this number within 24 hrs