A Non-significant Risk Clinical Study: Changes in Perfusion After Therapeutic Ultrasound in Patients With PAD

NCT05149664 | Active Not Recruiting FDA Device

• 1 other identifier: S21-002 (Prelude Study)
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

All evaluable subjects will receive VibratoSleeve therapeutic ultrasound (TUS) treatments. The device will be programmed to deliver TUS at a pre-determined level. Three different acoustic intensity levels will be tested during the first three treatment visits (one at each visit day). The most effective treatment that is comfortable to a subject will be prescribed for the remaining treatment sessions. Treatment time will be 90 minutes per session, one session per day. Thirty treatment sessions will be performed over a 45-day period. Subjects will appear for on-site follow-up visits at 1-, 3-, and 6-months following subject's last (30th) treatment session.

Conditions

Peripheral Arterial Disease (PAD)

Keywords

Therapeutic Ultrasound (TUS)

Outcome Measures

Primary Outcomes (1)

• Changes in foot perfusion

  (2) Mean difference between pre-treatment (baseline) and post-treatment, and at the 1-, 3-, and 6-months post-treatment follow up visits, using Clarifi Imaging System (Modulim), which uses spatial frequency domain imaging (SFDI), to measure tissue oxygen saturation (StO2) and tissue hemoglobin (Hb) in the dermal microcirculation (HbT1) and macrocirculation (HbT2) to assess lower extremity blood supply.

  Through study completion, an average of 6 months

Secondary Outcomes (2)

• Subject Questionnaire

  Through study completion, an average of 6 months.

• Adverse Events

  Through study completion, an average of 6 months.

Study Arms (1)

VibratoSleeve TUS

EXPERIMENTAL

Subjects will receive 30 TUS treatments, each one lasting 90 minutes on the calf of a leg with peripheral arterial disease.

Device: Therapeutic ultrasound (TUS)

Interventions

Therapeutic ultrasound (TUS) DEVICE

As described elsewhere, a sleeve is wrapped around the subject's targeted calf such that the inner lining with attached transducers are positioned around the calf muscle, with a gel-skin interface. The ultrasound energy is transmitted from these transducers to the deeper layers of the muscle.

VibratoSleeve TUS

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥22
• Diagnosis of infrapopliteal PAD.
• Rutherford class 3, 4 or 5 as determined by the investigator.
• Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg.

You may not qualify if:

• 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 all other criteria are met).
• 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%.
• 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.
• 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).
• Eligibility for patients with bi-lateral PAD will be assessed based on the leg that has more advanced PAD. For bi-lateral PAD patients only one leg with the more advanced bi-lateral PAD will be treated.

Sponsors & Collaborators

• Vibrato Medical, Inc.: lead

Study Sites (1)

Vascular & Interventional Specialists of Orange County

Orange, California, 92868, United States

Location

Related Publications (1)

• 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.

  PMID: 26062950 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/R
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single arm, open-label design of the VibratoSleeve TUS device.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: December 8, 2021
• Study Start: January 14, 2022
• Primary Completion: February 10, 2023
• Study Completion: December 1, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)