Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02866656
Recruitment Status : Unknown
Verified August 2016 by Junli Duan, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Junli Duan, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Arteriosclerosis Other: Conventional conservative treatment Device: therapeutic ultrasound Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Research of Low Intensity Continuous Ultrasonic on Lower Limb Arteriosclerosis Occlusion(ASO) Syndrome
Study Start Date : September 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: control group
patients were given Conventional conservative treatment;
Other: Conventional conservative treatment
Treatment last for 4 weeks, three times a week,

Experimental: therapeutic ultrasound group
patients were given Conventional conservative treatment and low intensity ultrasonic treatment ;
Other: Conventional conservative treatment
Treatment last for 4 weeks, three times a week,

Device: therapeutic ultrasound
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 Measures :
  1. Improvement of ankle brachial ratio at 4 weeks of treatment [ Time Frame: 4weeks ]

Secondary Outcome Measures :
  1. Improvement of local skin temperature at 4 weeks of treatment [ Time Frame: 4weeks ]
  2. Recovery of ultrasonic blood vessels at 4 weeks of treatment [ Time Frame: 4weeks ]
  3. Enhancement of the value of muscle enzymes at 4 weeks of treatment [ Time Frame: 4weeks ]
  4. Elevation of the value of hepatic and kidney function at 4 weeks of treatment [ Time Frame: 4weeks ]
  5. Improvement of the farthest distance Walking at 4 weeks of treatment [ Time Frame: 4weeks ]
  6. Changes of percutaneous tissue oxygen tension at 4 weeks of treatment [ Time Frame: 4weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Layout table for additonal information
Responsible Party: Junli Duan, Deputy director of the department of Gerontology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02866656     History of Changes
Other Study ID Numbers: XH-16-007
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases