Ultrasound Cavitation Therapy for Peripheral Arterial Disease

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Virginia

Disqualifiers: Severe heart failure, Pregnancy, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

In this study, we will explore how ultrasound exposure of ultrasound contrast agents, which produces beneficial shear-mediated bioeffects, can be used to treat patients with severe non-healing ulcers secondary to peripheral arterial disease (PAD). The primary outcome measure is whether ultrasound exposure to microbubble contrast agents in the inflow artery and at the wound site can accelerate wound healing. A secondary outcome measure is whether cavitation-related changes occur in tissue perfusion in the treated limb and wound measured by ultrasound perfusion imaging and skin flow.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Ultrasound Cavitation Therapy for Peripheral Arterial Disease?

Research shows that ultrasound treatment can improve blood flow and circulation in patients with atherosclerotic lesions in the legs. Additionally, ultrasound combined with other agents has been effective in breaking down blood clots in animal models, suggesting potential benefits for similar conditions.

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How is Ultrasound Cavitation Therapy different from other treatments for Peripheral Arterial Disease?

Ultrasound Cavitation Therapy is unique because it uses sound waves to create tiny bubbles that help improve blood flow in the affected areas, unlike traditional treatments that often rely on drugs or surgery. This method can enhance circulation without the bleeding risks associated with standard thrombolytic (clot-dissolving) therapies.

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Eligibility Criteria

This trial is for people with severe non-healing ulcers due to Peripheral Arterial Disease (PAD), specifically those who have not seen any improvement in the past 3 months. Participants must have a confirmed PAD diagnosis and be classified as having Critical Limb Ischemia. Those with major illnesses affecting the limb, pregnant or breastfeeding women, allergies to ultrasound contrast agents or PEG, unstable blood pressure, or upcoming amputation are excluded.

Inclusion Criteria

I have severe leg artery disease with a non-healing wound for over 3 months.

I have been diagnosed with PAD due to low ankle-brachial index or non-compressible vessels.

Exclusion Criteria

You are allergic to ultrasound contrast agents or polyethylene glycol.

I am expected to undergo amputation or a procedure to restore blood flow within the next month.

Pregnant or lactating females

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ultrasound cavitation therapy to treat non-healing ulcers

18 days

Follow-up

Participants are monitored for changes in wound granulation and tissue perfusion

4 weeks

Participant Groups

The study tests if using ultrasound to shake microbubble contrast agents can help heal severe ulcers caused by poor blood flow in PAD patients. It looks at whether this treatment speeds up healing and improves blood flow in the affected limb compared to usual care without these ultrasound effects.

Group I: Cavitation therapy Experimental Treatment 1 Intervention

Subjects treated with cavitation energy

Group II: Control Active Control 1 Intervention

Control subjects not treated with cavitation energy

Ultrasound Cavitation Therapy is already approved in European Union, United States, Canada, Australia for the following indications:

🇪🇺 Approved in European Union as Ultrasonic Cavitation for:

• Body contouring
• Fat reduction
• Cellulite treatment

🇺🇸 Approved in United States as Ultrasonic Cavitation for:

• Body contouring
• Fat reduction
• Cellulite treatment

🇨🇦 Approved in Canada as Ultrasonic Cavitation for:

• Body contouring
• Fat reduction
• Cellulite treatment

🇦🇺 Approved in Australia as Ultrasonic Cavitation for:

• Body contouring
• Fat reduction
• Cellulite treatment

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Virginia Charlottesville, VA

Who Is Running the Clinical Trial?

University of Virginia Lead Sponsor

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The ultrasonic therapy of patients with arteriosclerosis obliterans of the vessels of the lower extremities]. [2006] Available are the results of low-dose ultrasound treatment given segmentally and locally on ischemia-affected tissues of the legs. Altogether 40 patients with atherosclerotic lesions of the vessels underwent this treatment. Positive response was evident from improved peripheral circulation, microcirculation and hemocoagulation.

2. United States pubmed.ncbi.nlm.nih.gov

Contrast-enhanced sonothrombolysis in a porcine model of acute peripheral arterial thrombosis and prevention of anaphylactic shock. [2014] Acute peripheral arterial thrombosis can be threatening to life and limb. Dissolution of the thrombus local catheter-directed intra-arterial infusion of fibrinolytic agents such as urokinase is the standard therapy for thrombosis; however, this method is time-intensive, and amputation of the affected limb is still needed in 10-30% of cases. Furthermore, thrombolytic therapy carries the risk of bleeding complications. The use of small gas-filled bubbles, or ultrasound contrast agents (UCAs), in combination with ultrasound has been investigated as an improved thrombolytic therapy in acute coronary and cerebral arterial thrombosis. The authors describe a porcine model of acute peripheral arterial occlusion to test contrast-enhanced sonothrombolysis approaches that combine ultrasound, UCAs and fibrinolytic agents and recommend a strategy for preventing severe allergic reactions to UCAs in the pigs.

3. United States pubmed.ncbi.nlm.nih.gov

Local Ultrasound to Enhance Paclitaxel Delivery After Femoral-Popliteal Treatment in Critical Limb Ischemia: The PACUS Trial. [2021] The aim of this study was to evaluate the safety and efficacy of percutaneous catheter-delivered ultrasound energy to improve local paclitaxel delivery effects in patients with critical limb ischemia (CLI) treated for femoral-popliteal arterial disease.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Intravenous Targeted Microbubbles Carrying Urokinase versus Urokinase Alone in Acute Peripheral Arterial Thrombosis in a Porcine Model. [2018] Standard therapy in acute peripheral arterial occlusion consists of intra-arterial catheter-guided thrombolysis. As microbubbles may be used as a carrier for fibrinolytic agents and targeted to adhere to the thrombus, we can theoretically deliver the thrombolytic medication locally following simple intravenous injection. In this intervention-controlled feasibility study, we compared intravenously administered targeted microbubbles incorporating urokinase and locally applied ultrasound, with intravenous urokinase and ultrasound alone.

5. Scotland pubmed.ncbi.nlm.nih.gov

The effectiveness of therapeutic ultrasound for musculoskeletal conditions of the lower limb: A literature review. [2011] Ultrasound is suggested as one of the treatment options available for soft tissue musculoskeletal conditions of the lower limb and to this end, the objective was to review the literature and evaluate the effectiveness of therapeutic ultrasound for musculoskeletal conditions of the lower limb.

6. England pubmed.ncbi.nlm.nih.gov

Low-intensity pulsed ultrasound in combination with SonoVue induces cytotoxicity of human renal glomerular endothelial cells via repression of the ERK1/2 signaling pathway. [2018] Low-intensity pulsed ultrasound (LIPUS) and SonoVue have been used widely for diagnosis and therapeutic treatment. The effects of LIPUS and SonoVue on the microvascular system and underlying molecular mechanisms have not been established.

7. United States pubmed.ncbi.nlm.nih.gov

Six-Month Angiographic and Clinical Outcomes of Therapeutic Ultrasound Pretreatment Associated With Plain Balloon Angioplasty for Below-the-Knee Lesions in Patients With Critical Limb Ischemia: A Prospective, Single-Center Pilot Study. [2022] To evaluate the safety and efficacy of low-frequency, high-intensity ultrasound energy delivered via a new dedicated ultrasound catheter followed by conventional balloon angioplasty to treat calcified infrapopliteal lesions.

8. United States pubmed.ncbi.nlm.nih.gov

Augmentation of Tissue Perfusion in Patients With Peripheral Artery Disease Using Microbubble Cavitation. [2021] The authors investigated ideal acoustic conditions on a clinical scanner custom-programmed for ultrasound (US) cavitation-mediated flow augmentation in preclinical models. We then applied these conditions in a first-in-human study to test the hypothesis that contrast US can increase limb perfusion in normal subjects and patients with peripheral artery disease (PAD).