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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2024-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes

NCT01855412

Peripheral Arterial Occlusive Disease

COMPLETED

Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease

NCT01588067

Peripheral Arterial Disease

COMPLETED

Duplex UltraSound afTer Endo Revascularisation - Feasibility Randomised Control Trial (DUSTER)

NCT06702306

Chronic Limb Threatening Ischaemia

ACTIVE_NOT_RECRUITING NA

VascTrac Peripheral Arterial Disease (PAD) Study

NCT03048890

Peripheral Artery Disease Intermittent Claudication

UNKNOWN

Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

NCT01938391

Peripheral Artery Disease PAD Claudication +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single arm, open-label, feasibility acute phase study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TUS Therapy

These subjects will undergo treatments with the Vibrato Sleeve TUS device.

Group Type EXPERIMENTAL

VibratoSleeve Therapeutic Ultrasound Device

Intervention Type DEVICE

The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VibratoSleeve Therapeutic Ultrasound Device

The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 65
2. Diagnosis of PAD.
3. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator.

Exclusion Criteria

1. Prior stenting in posterior tibial artery.
2. Re-vascularization procedure within 30 days prior to enrollment in the study.
3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
4. History or diagnosis of severe chronic venous insufficiency.
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. 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.
8. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period.

stenting in posterior tibial artery.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes