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
About this trial
This is an interventional treatment trial for Arteriosclerosis
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
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
NCT ID
NCT02866656
First Posted
April 12, 2016
Last Updated
August 12, 2016
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
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