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

Primary Purpose

Peripheral Arterial Disease

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Sonodynamic therapy(SDT)

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sonodynamic therapy(SDT)

Arm Description

Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure.

Outcomes

Primary Outcome Measures

Change in PVAT Density, as assessed by CTA

The changes in CT attenuation (HU) of perivascular adipose tissue(PVAT) as assessed by CTA.

Secondary Outcome Measures

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.

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.

Incidence of adverse events

Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction

Plasma adipokines level

Including adiponectin, vaspin, apelin, leptin, visfatin, resistin and FABP

Plasma inflammation cytokine level

Including Interleukin-6(IL-6), IL-10, IL-1β, TGF-α, CRP, EGF, glutathione(GSH) and TGSH.

Full Information

NCT ID

NCT03967730

First Posted

May 27, 2019

Last Updated

April 13, 2021

Sponsor

First Affiliated Hospital of Harbin Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03967730

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Withdrawn

Why Stopped

COVID-19

Study Start Date

June 20, 2019 (Anticipated)

Primary Completion Date

May 30, 2020 (Anticipated)

Study Completion Date

May 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital of Harbin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sonodynamic therapy(SDT)

Arm Type

Experimental

Arm Description

Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure.

Intervention Type

Combination Product

Intervention Name(s)

Sonodynamic therapy(SDT)

Intervention Description

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%.

Primary Outcome Measure Information:

Title

Change in PVAT Density, as assessed by CTA

Description

The changes in CT attenuation (HU) of perivascular adipose tissue(PVAT) as assessed by CTA.

Time Frame