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COVID-19
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonodynamic therapy(SDT) | Experimental | Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PVAT Density, as assessed by CTA | The changes in CT attenuation (HU) of perivascular adipose tissue(PVAT) as assessed by CTA. | Measured at Baseline, 1, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at Baseline, 1, 3 months |
| Change in peak flow velocity, as assessed by doppler ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ye Tian, MD,PHD | First Affiliated Hospital of Harbin Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
The changes of the systolic and diastolic peak flow velocity of the affected segments by doppler ultrasound. |
| Measured at Baseline, 1, 3 months |
| Incidence of adverse events | Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction | Measured at Baseline, 1, 3 months |
| Plasma adipokines level | Including adiponectin, vaspin, apelin, leptin, visfatin, resistin and FABP | 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 at Baseline, 1, 3 months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |