CompletedNot Applicable

A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD

United States29 participantsStarted 2023-03-13

Plain-language summary

The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. Age ≥22.
✓. Diagnosis of infrapopliteal PAD.
✓. Rutherford class 4 or 5 as determined by the investigator.
✓. Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg.

Exclusion criteria

✕. Prior stenting in posterior tibial, anterior tibial or peroneal artery.
✕. 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).
✕. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
✕. History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
✕. Acute limb ischemia within 30 days prior to treatment.
✕. History or diagnosis of deep venous thrombosis below the knee in treatment leg.
✕. Uncontrolled diabetes defined as HbA1c greater than 10%.
✕. Ongoing hyperbaric oxygen treatment (HBOT)

What they're measuring

Changes in foot perfusion

Timeframe: 4 months

Trial details

NCT IDNCT05100745

SponsorVibrato Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Peripheral Arterial Disease trials