The Clinical Research of Low Intensity Continuous Ultrasonic on Lower Limb Arteriosclerosis Occlusion（ASO） Syndrome

NCT02866656 | Unknown DMC

• 1 other identifier: XH-16-007
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the present study, by evaluating the efficacy and safety of low intensity ultrasonic on ASO, to explore the noninvasive auxiliary treatment of ASO. 90 patients were randomly divided into 2 groups: A)control group, patients were given Conventional conservative treatment; B）treatment group, patients were given Conventional conservative treatment and low intensity ultrasonic treatment ; Treatments last for 4 weeks, three times a week, stimulation was given 8 minutes every time, location of treatment were lower limb ischemia area and its surrounding tissues; outcome indicators were recorded Before and 4 weeks after the trial, The Walking Impairment Questionnaire (WIQ), ankle brachial ratio, the farthest distance Walking, percutaneous tissue oxygen tension, tissue oxygenation index recovery time, local skin temperature, ultrasonic blood vessels, and muscle enzymes, hepatic and kidney function.

Conditions

Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• Improvement of ankle brachial ratio at 4 weeks of treatment

  4weeks

Secondary Outcomes (6)

• Improvement of local skin temperature at 4 weeks of treatment

  4weeks

• Recovery of ultrasonic blood vessels at 4 weeks of treatment

  4weeks

• Enhancement of the value of muscle enzymes at 4 weeks of treatment

  4weeks

• Elevation of the value of hepatic and kidney function at 4 weeks of treatment

  4weeks

• Improvement of the farthest distance Walking at 4 weeks of treatment

  4weeks

Study Arms (2)

control group

EXPERIMENTAL

patients were given Conventional conservative treatment；

Other: Conventional conservative treatment

therapeutic ultrasound group

EXPERIMENTAL

patients were given Conventional conservative treatment and low intensity ultrasonic treatment ；

Other: Conventional conservative treatment; Device: therapeutic ultrasound

Interventions

Conventional conservative treatment OTHER

Treatment last for 4 weeks, three times a week,

control group; therapeutic ultrasound group

therapeutic ultrasound DEVICE

Treatment last for 4 weeks, three times a week, stimulation was given 8 minutes every time, location of treatment were lower limb ischemia area and its surrounding tissues；

therapeutic ultrasound group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• lower limb arteriosclerosis occlusion disorder patients
• In line with the Fontaine II - Ⅲ period clinical stage
• Aged 35 to 70 years old
• No major organ dysfunction, including heart, liver and kidney
• Can understand the procedures and methods of the test, strictly observe clinical trial plan to complete the test, and sign the informed consent

You may not qualify if:

• Fontaine clinical staging in patients with stage I
• Aged under 35 or more than 70 - year - old patient
• Women with pregnancy or lactation
• Childless and one year plan pregnancy
• Patients with cardiac pacemaker
• Patients with malignant tumor, psychosis
• Accompanied by severe heart, brain, kidney and hematopoietic system disease
• The following appeared in the process of being test: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass grafts, heart failure, cerebrovascular accident (including transient ischemic attack); And epilepsy, severe liver and kidney function is not complete, mechanical intestinal obstruction, bradycardia, bronchial asthma and other diseases
• Researchers think the patient has any problem that may cause the participants can't finish this research ，or any other situation of risk to participants

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Arteriosclerosis

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of the department of Gerontology

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: August 15, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 15, 2016

Record last verified: 2016-08