N/A
N=12
Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT05888740 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Mean Acute Flow Rate Difference During TUS Treatment Sessions — 27.3 Percent change (%)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VibratoSleeve Therapeutic Ultrasound Device (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Vibrato Medical, Inc.
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Acute Flow Rate Difference During TUS Treatment Sessions |
27.3 | — |
| PRIMARY Tissue Oxygen Saturation (StO2) |
1.0 | — |
| PRIMARY Ankle Brachial Index (ABI) |
0.0 | — |
| SECONDARY Incidence of Device and Procedure-related Adverse Events |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05888740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.