Therapeutic ultrasound (TUS): 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.
Study 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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥22
2. Diagnosis of infrapopliteal PAD.
3. Rutherford class 3, 4 or 5 as determined by the investigator.
4. Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg.
Exclusion Criteria:
1. Prior stenting in posterior tibial, anterior tibial or peroneal artery.
2. 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).
3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
4. History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
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. Uncontrolled diabetes defined as HbA1c greater than 10%.
8. 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.
9. 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.
Primary outcome measure(s)
Changes in foot perfusion — Through study completion, an average of 6 months (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.
Trial sites (1)
Facility
City
Region
Status
Vascular & Interventional Specialists of Orange County
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.