Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With PAD and Claudication

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 15, 2018

Primary Completion Date

December 18, 2018

Study Completion Date

April 11, 2019

Conditions
Peripheral Arterial DiseaseAtherosclerosisCardiovascular Diseases
Interventions
COMBINATION_PRODUCT

OMC and pseudo-SDT

OMC is established according to the 2016 ACC-AHA Guidelines for the Management of Patients with PAD. Pseudo-SDT combines saline injection and obstructed ultrasound exposure on targeted lesions to simulate real SDT progression.

COMBINATION_PRODUCT

OMC and SDT

OMC is established according to the 2016 ACC-AHA Guidelines for the Management of Patients with PAD. SDT treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. 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 of each lesion.

Trial Locations (1)

150000

The First Affiliated Hospital of Harbin Medical University, Harbin

All Listed Sponsors
lead

First Affiliated Hospital of Harbin Medical University

OTHER

NCT03457662 - Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With PAD and Claudication | Biotech Hunter | Biotech Hunter