A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD
NCT ID: NCT05100745
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2023-03-13
2024-12-11
Brief Summary
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Detailed Description
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Those randomized to the control arm will undergo therapy sessions with a sham Vibrato Sleeve device and two months of follow-up. Upon completion of the 2-month follow-up visit, subjects will be informed of their randomization assignment. Subjects in the sham arm will be allowed to crossover to a treatment regimen that uses an active Vibrato Sleeve device and will follow the same visit schedule as the active test group.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Activated Therapy
Therapy: these subjects will undergo 30 treatments with an activated Vibratosleeve TUS device.
Therapeutic Device
This device delivers ultrasound energy to the targeted area of the lower limb.
Sham Therapy
An inactive (sham) device will be used in these subjects for the first 30 treatments followed by a 30-treatment regimen with an activated VibratoSleeve TUS device after crossover.
Therapeutic Device
This device delivers ultrasound energy to the targeted area of the lower limb.
Interventions
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Therapeutic Device
This device delivers ultrasound energy to the targeted area of the lower limb.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of infrapopliteal PAD.
3. Rutherford class 4 or 5 as determined by the investigator.
4. Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg.
Exclusion Criteria
2. Re-vascularization procedure within 25 days prior to enrollment in the study. (Note: Patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if they meet other criteria).
3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
4. History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
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. Uncontrolled diabetes defined as HbA1c greater than 10%.
8. Ongoing hyperbaric oxygen treatment (HBOT)
9. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study or lead to difficulties for patient compliance with study requirements, or could confound study data.
9\. Patient's enrollment in another investigational study that has not completed the required primary endpoint follow-up period (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
22 Years
ALL
No
Sponsors
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Vibrato Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Vascular & Interventional Specialists of Orange County
Orange, California, United States
Countries
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References
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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.
Other Identifiers
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21-001
Identifier Type: -
Identifier Source: org_study_id
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