CompletedNot Applicable

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

United States12 participantsStarted 2023-02-22

Plain-language 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.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mean Acute Flow Rate Difference During TUS Treatment Sessions

Timeframe: Baseline to end of treatment, an average of 1 month

Tissue Oxygen Saturation (StO2)

Timeframe: Through study completion, an average of 1 month

Ankle Brachial Index (ABI)

Timeframe: Baseline to end of treatment, an average of 1 month

Trial details

NCT IDNCT05888740

SponsorVibrato Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-10

Results submitted2025-04-15

View on ClinicalTrials.gov More Peripheral Arterial Disease trials

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mean Acute Flow Rate Difference During TUS Treatment Sessions

Timeframe: Baseline to end of treatment, an average of 1 month

Tissue Oxygen Saturation (StO2)

Timeframe: Through study completion, an average of 1 month

Ankle Brachial Index (ABI)

Timeframe: Baseline to end of treatment, an average of 1 month