Peripheral Arterial DiseasePhase 1/2NCT03967730
Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication
A Phase 1/2 study testing Sonodynamic therapy(SDT) in people with Peripheral Arterial Disease, run by First Affiliated Hospital of Harbin Medical University.
Trial summary
The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) in reducing the inflammation of perivascular adipose tissue and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients with symptom of intermittent claudication. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Sonodynamic therapy(SDT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2019to 30 May 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40-80 years
- Patients with atherosclerotic peripheral artery disease with symptoms of moderate to severe intermittent claudication (defined as ability to walk at least 2, but not more than 11 minutes on a graded treadmill test using the Gardner protocol)
- Femoral popliteal artery with 50% stenosis by ultrasound
- Stable use of low to moderate dose statin and the permitted statin drugs/ doses: atorvastatin 20 mg, simvastatin 40 mg, rosuvastatin 10 mg, pravastatin, 40 mg, fluvastatin 80 mg or lovastatin 40 mg for at least 6 weeks prior to screening
- Written informed consent
Who cannot join
- Severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments
- Critical limb ischemia or other comorbid conditions that limit walking ability
- Non-atherosclerotic peripheral artery stenosis
- Active systemic inflammatory disease or have an infectious disease within 1 month prior to enrollment
- Systemic disorders such as hepatic, renal, hematologic, and malignant disease
- Allergic to contrast media with iodine
Show all 11Show fewer
- Contraindication to CTA
- Allergic to DVDMS
- Diagnosis of porphyria
- Pregnant women and nursing mothers
- Patient who is attending other clinical trial
About this study
The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) in reducing the inflammation of perivascular adipose tissue and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients with symptom of intermittent claudication.
Read the detailed description
Atherosclerotic lower extremity PAD affects the living quality of more than 20 million people in the world. PAD is associated with a major decline in functional status and claudication is the most evident symptom. Current claudication therapies reveal significant limitations. Pharmacotherapy and exercise are recommended in 2016 AHA/ACC Guideline on the management of lower extremity PAD patients with claudication. However, they may not achieve an ideal clinical therapeutic effect. Furthermore, endovascular procedure may not be feasible, durable or cost-effective, especially in femoropopliteal arteries.
The aim of this trial is to verify the hypothesis that SDT can reduce the inflammation of PVAT and improve PWT among PAD patients with symptom of intermittent claudication.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Sonodynamic therapy(SDT)
- 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.
Sonodynamic therapy(SDT)Combination product
Sonodynamic Therapy (SDT) Sinoporphyrin Sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection(0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15 min of each lesion. Ultrasound parameters included intensity of 2.1W/cm2 for each lesion, resonance frequency: 1.0 MHz and duty factor: 30%.
| Study group | Role | What they receive |
|---|---|---|
| Sonodynamic therapy(SDT) | Experimental | Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. Receives: Combination Product: Sonodynamic therapy(SDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PVAT Density, as assessed by CTA
The changes in CT attenuation (HU) of perivascular adipose tissue(PVAT) as assessed by CTA.
Measured: Measured at Baseline, 1, 3 months
Secondary outcomes (5)
PWT change, mins
Changes from baseline peak walking time (PWT) at 1 month is assessed by graded treadmill test (Gardner protocol). The patient continues the test until walking can no longer be tolerated because of claudication symptoms.
Measured: Measured at Baseline, 1, 3 months
Change in peak flow velocity, as assessed by doppler ultrasound
The changes of the systolic and diastolic peak flow velocity of the affected segments by doppler ultrasound.
Measured: Measured at Baseline, 1, 3 months
Incidence of adverse events
Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction
Measured: Measured at Baseline, 1, 3 months
Plasma adipokines level
Including adiponectin, vaspin, apelin, leptin, visfatin, resistin and FABP
Measured: Measured at Baseline, 1, 3 months
Plasma inflammation cytokine level
Including Interleukin-6(IL-6), IL-10, IL-1β, TGF-α, CRP, EGF, glutathione(GSH) and TGSH.
Measured: Measured at Baseline, 1, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start20 Jun 2019 (estimated)
- Primary completion30 May 2020 (estimated)
- Study completion30 May 2020 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ye Tian, MD,PHD, Principal investigator, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967730
- Sponsor's protocol ID
- Ye Tian PVAT
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication
- ClinicalTrials.gov ID
- NCT03967730
- Acronym / sponsor ID
- Ye Tian PVAT
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2019 (estimated)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 30 May 2019 (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.
The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) in reducing the inflammation of perivascular adipose tissue and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients with symptom of intermittent claudication.
Detailed description
Atherosclerotic lower extremity PAD affects the living quality of more than 20 million people in the world. PAD is associated with a major decline in functional status and claudication is the most evident symptom. Current claudication therapies reveal significant limitations. Pharmacotherapy and exercise are recommended in 2016 AHA/ACC Guideline on the management of lower extremity PAD patients with claudication. However, they may not achieve an ideal clinical therapeutic effect. Furthermore, endovascular procedure may not be feasible, durable or cost-effective, especially in femoropopliteal arteries.
The aim of this trial is to verify the hypothesis that SDT can reduce the inflammation of PVAT and improve PWT among PAD patients with symptom of intermittent claudication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonodynamic therapy(SDT) | Experimental | Combination Product: Sonodynamic therapy(SDT)Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 40-80 years
- Patients with atherosclerotic peripheral artery disease with symptoms of moderate to severe intermittent claudication (defined as ability to walk at least 2, but not more than 11 minutes on a graded treadmill test using the Gardner protocol)
- Femoral popliteal artery with 50% stenosis by ultrasound
- Stable use of low to moderate dose statin and the permitted statin drugs/ doses: atorvastatin 20 mg, simvastatin 40 mg, rosuvastatin 10 mg, pravastatin, 40 mg, fluvastatin 80 mg or lovastatin 40 mg for at least 6 weeks prior to screening
- Written informed consent
Key exclusion criteria (11 listed)
- Severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments
- Critical limb ischemia or other comorbid conditions that limit walking ability
- Non-atherosclerotic peripheral artery stenosis
- Active systemic inflammatory disease or have an infectious disease within 1 month prior to enrollment
- Systemic disorders such as hepatic, renal, hematologic, and malignant disease
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 |
|---|---|---|
| Sonodynamic therapy(SDT)Sonodynamic Therapy (SDT) Sinoporphyrin Sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection(0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15 min of each lesion. Ultrasound parameters included intensity of 2.1W/cm2 for each lesion, resonance frequency: 1.0 MHz and duty factor: 30%. | Combination product | Sonodynamic therapy(SDT) |
Primary outcome
Change in PVAT Density, as assessed by CTA
Time frame: Measured at Baseline, 1, 3 months
The changes in CT attenuation (HU) of perivascular adipose tissue(PVAT) as assessed by CTA.
5 secondary outcomes
PWT change, mins
Time frame: Measured at Baseline, 1, 3 months
Change in peak flow velocity, as assessed by doppler ultrasound
Time frame: Measured at Baseline, 1, 3 months
Incidence of adverse events
Time frame: Measured at Baseline, 1, 3 months
Plasma adipokines level
Time frame: Measured at Baseline, 1, 3 months
Plasma inflammation cytokine level
Time frame: Measured at Baseline, 1, 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
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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. This study is not recruiting at the moment.
Ye Tian, MD,PHD principal investigator
First Affiliated Hospital of Harbin Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sonodynamic therapy(SDT) in people with Peripheral Arterial Disease, run by First Affiliated Hospital of Harbin Medical University.
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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PVAT Density, as assessed by CTA (time frame: Measured at Baseline, 1, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2021.