Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication

Peripheral Arterial Disease Clinical Trial

Official title:

Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03967730
• Other study ID #: Ye Tian PVAT
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: June 20, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: May 2019
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Contraindication to CTA

• Allergic to DVDMS

• Diagnosis of porphyria

• Pregnant women and nursing mothers

• Patient who is attending other clinical trial

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Combination Product:
• 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%.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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 at Baseline, 1, 3 months
Secondary	Incidence of adverse events	Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction	Measured at Baseline, 1, 3 months
Secondary	Plasma adipokines level	Including adiponectin, vaspin, apelin, leptin, visfatin, resistin and FABP	Measured at Baseline, 1, 3 months
Secondary	Plasma inflammation cytokine level	Including Interleukin-6(IL-6), IL-10, IL-1ß, TGF-a, CRP, EGF, glutathione(GSH) and TGSH.	Measured at Baseline, 1, 3 months