search
Back to results

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

Primary Purpose

Arteriosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional conservative treatment
therapeutic ultrasound
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriosclerosis

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    control group

    therapeutic ultrasound group

    Arm Description

    patients were given Conventional conservative treatment;

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

    Outcomes

    Primary Outcome Measures

    Improvement of ankle brachial ratio at 4 weeks of treatment

    Secondary Outcome Measures

    Improvement of local skin temperature at 4 weeks of treatment
    Recovery of ultrasonic blood vessels at 4 weeks of treatment
    Enhancement of the value of muscle enzymes at 4 weeks of treatment
    Elevation of the value of hepatic and kidney function at 4 weeks of treatment
    Improvement of the farthest distance Walking at 4 weeks of treatment
    Changes of percutaneous tissue oxygen tension at 4 weeks of treatment

    Full Information

    First Posted
    April 12, 2016
    Last Updated
    August 12, 2016
    Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02866656
    Brief Title
    The Clinical Research of Low Intensity Continuous Ultrasonic on Lower Limb Arteriosclerosis Occlusion(ASO) Syndrome
    Official Title
    The Clinical Research of Low Intensity Continuous Ultrasonic on Lower Limb Arteriosclerosis Occlusion(ASO) Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    October 2018 (Anticipated)
    Study Completion Date
    October 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Ultrasound is a form of sound whose frequency is higher than the natural audible range for humans (> 20 kHz) and ultrasonography has been widely used as diagnostic devices for several decades. In addition to diagnostic purposes, ultrasound is clinically used for therapeutic applications, including tumor ablation, thrombolysis, bone regeneration, and facilitated drug delivery. Recently, therapeutic angiogenic effects of low-intensity ultrasound have been reported in endothelial cells, chick chorioallantoic membrane, and a rat model of hind limb ischemia. the investigators hypothesis low-intensity ultrasound can improve the ailment of ASO. 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. the investigators speculate after 4 weeks of Low intensity ultrasonic treatment, all the observation index of ASO patients can be improved; meanwhile, creatine kinase, liver and kidney function, blood in urine routine, electrocardiogram (ecg) has no obvious change.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Experimental
    Arm Description
    patients were given Conventional conservative treatment;
    Arm Title
    therapeutic ultrasound group
    Arm Type
    Experimental
    Arm Description
    patients were given Conventional conservative treatment and low intensity ultrasonic treatment ;
    Intervention Type
    Other
    Intervention Name(s)
    Conventional conservative treatment
    Intervention Description
    Treatment last for 4 weeks, three times a week,
    Intervention Type
    Device
    Intervention Name(s)
    therapeutic ultrasound
    Intervention Description
    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;
    Primary Outcome Measure Information:
    Title
    Improvement of ankle brachial ratio at 4 weeks of treatment
    Time Frame
    4weeks
    Secondary Outcome Measure Information:
    Title
    Improvement of local skin temperature at 4 weeks of treatment
    Time Frame
    4weeks
    Title
    Recovery of ultrasonic blood vessels at 4 weeks of treatment
    Time Frame
    4weeks
    Title
    Enhancement of the value of muscle enzymes at 4 weeks of treatment
    Time Frame
    4weeks
    Title
    Elevation of the value of hepatic and kidney function at 4 weeks of treatment
    Time Frame
    4weeks
    Title
    Improvement of the farthest distance Walking at 4 weeks of treatment
    Time Frame
    4weeks
    Title
    Changes of percutaneous tissue oxygen tension at 4 weeks of treatment
    Time Frame
    4weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs