Peripheral Arterial DiseaseNCT05749250
Ultrasound Cavitation Therapy for CLI
A study testing Acoustic cavitation of ultrasound enhancing agents in people with Peripheral Arterial Disease, run by University of Virginia at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Acoustic cavitation of ultrasound enhancing agents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 28 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (<0.9) or non-compressible vessels
- Diagnosis of CLI (Rutherford class IV-VI), and a non-healing ischemic ulcer defined as no change in the prior 3 months.
Who cannot join
- Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure [NYHA class IV]).
- Pregnant or lactating females
- Hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (PEG, macrogol).
- Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors).
- Expected amputation or revascularization procedure within the ensuing 1 month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Jonathan Lindner, MD, 434-297-9442, jlindner@virginia.edu
About this study
Official title: Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Acoustic cavitation of ultrasound enhancing agents
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic cavitation of ultrasound enhancing agentsDevice
Cavitation therapy
| Study group | Role | What they receive |
|---|---|---|
| Cavitation therapy | Experimental | Subjects treated with cavitation energy Receives: Device: Acoustic cavitation of ultrasound enhancing agents |
| Control | No intervention | Control subjects not treated with cavitation energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound dimensions
Area of non-healing ulcer
Measured: 18 days
Secondary outcomes (2)
Wound granulation
Area of granulation tissue of the ulcer
Measured: 18 days
Tissue perfusion
Laser speckle perfusion imaging
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Jan 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Lindner, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749250
- Sponsor's protocol ID
- HSR220344
- Status last verified
- Feb 2023
- First submitted
- 25 Oct 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gholson BA, Morello M, Capdeville S, Belcik JT, Hodovan J, Choi Y, Abraham-Fan RJ, Nguyen KP, Davidson BP, Powers J, Lindner JR. Ultrasound Cavitation of Microbubbles Augments Limb Perfusion and Promotes Ulcer Healing in Chronic Limb-Threatening Ischemia. JACC Cardiovasc Imaging. 2026 Oct;19(10):1171-1182. doi: 10.1016/j.jcmg.2026.06.009. Epub 2026 Aug 4.
PubMed 42554561
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT05749250
- Acronym / sponsor ID
- HSR220344
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cavitation therapy | Experimental | Device: Acoustic cavitation of ultrasound enhancing agentsSubjects treated with cavitation energy |
| Control | No intervention | –Control subjects not treated with cavitation energy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (<0.9) or non-compressible vessels
- Diagnosis of CLI (Rutherford class IV-VI), and a non-healing ischemic ulcer defined as no change in the prior 3 months.
Key exclusion criteria (5 listed)
- Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure [NYHA class IV]).
- Pregnant or lactating females
- Hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (PEG, macrogol).
- Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors).
- Expected amputation or revascularization procedure within the ensuing 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic cavitation of ultrasound enhancing agentsCavitation therapy | Device | Cavitation therapy |
Primary outcome
Wound dimensions
Time frame: 18 days
Area of non-healing ulcer
2 secondary outcomes
Wound granulation
Time frame: 18 days
Tissue perfusion
Time frame: 18 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 42554561Gholson BA, Morello M, Capdeville S, Belcik JT, Hodovan J, Choi Y, Abraham-Fan RJ, Nguyen KP, Davidson BP, Powers J, Lindner JR. Ultrasound Cavitation of Microbubbles Augments Limb Perfusion and Promotes Ulcer Healing in Chronic Limb-Threatening Ischemia. JACC Cardiovasc Imaging. 2026 Oct;19(10):1171-1182. doi: 10.1016/j.jcmg.2026.06.009. Epub 2026 Aug 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic cavitation of ultrasound enhancing agents in people with Peripheral Arterial Disease, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Lindner, MD (434 297-9442, jlindner@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound dimensions (time frame: 18 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05749250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.