ArteriosclerosisNCT02866656
The Clinical Research of Low Intensity Continuous Ultrasonic on Lower Limb Arteriosclerosis Occlusion（ASO） Syndrome
A study testing Conventional conservative treatment and therapeutic ultrasound in people with Arteriosclerosis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Arteriosclerosis
- What is being tested?
- Conventional conservative treatment and therapeutic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: The Clinical Research of Low Intensity Continuous Ultrasonic on Lower Limb Arteriosclerosis Occlusion(ASO) Syndrome
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.
Read the 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.
- Conditions
- Arteriosclerosis
- Being tested
- Conventional conservative treatment, therapeutic ultrasound
- Medical subject headings
- Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional conservative treatmentOther
Treatment last for 4 weeks, three times a week,
therapeutic ultrasoundDevice
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；
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | patients were given Conventional conservative treatment； Receives: Other: Conventional conservative treatment |
| therapeutic ultrasound group | Experimental | patients were given Conventional conservative treatment and low intensity ultrasonic treatment ； Receives: Other: Conventional conservative treatment; Device: therapeutic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of ankle brachial ratio at 4 weeks of treatment
Measured: 4weeks
Secondary outcomes (6)
Improvement of local skin temperature at 4 weeks of treatment
Measured: 4weeks
Recovery of ultrasonic blood vessels at 4 weeks of treatment
Measured: 4weeks
Enhancement of the value of muscle enzymes at 4 weeks of treatment
Measured: 4weeks
Elevation of the value of hepatic and kidney function at 4 weeks of treatment
Measured: 4weeks
Improvement of the farthest distance Walking at 4 weeks of treatment
Measured: 4weeks
Changes of percutaneous tissue oxygen tension at 4 weeks of treatment
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junli Duan, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866656
- Sponsor's protocol ID
- XH-16-007
- Status last verified
- Aug 2016
- First submitted
- 12 Apr 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research of Low Intensity Continuous Ultrasonic on Lower Limb Arteriosclerosis Occlusion(ASO) Syndrome
- ClinicalTrials.gov ID
- NCT02866656
- Acronym / sponsor ID
- XH-16-007
- Conditions
- Arteriosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: Conventional conservative treatmentpatients were given Conventional conservative treatment； |
| therapeutic ultrasound group | Experimental | Other: Conventional conservative treatment, Device: therapeutic ultrasoundpatients were given Conventional conservative treatment and low intensity ultrasonic treatment ； |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional conservative treatmentTreatment last for 4 weeks, three times a week, | Other | control group, therapeutic ultrasound group |
| therapeutic ultrasoundTreatment 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； | Device | therapeutic ultrasound group |
Primary outcome
Improvement of ankle brachial ratio at 4 weeks of treatment
Time frame: 4weeks
6 secondary outcomes
Improvement of local skin temperature at 4 weeks of treatment
Time frame: 4weeks
Recovery of ultrasonic blood vessels at 4 weeks of treatment
Time frame: 4weeks
Enhancement of the value of muscle enzymes at 4 weeks of treatment
Time frame: 4weeks
Elevation of the value of hepatic and kidney function at 4 weeks of treatment
Time frame: 4weeks
Improvement of the farthest distance Walking at 4 weeks of treatment
Time frame: 4weeks
Changes of percutaneous tissue oxygen tension at 4 weeks of treatment
Time frame: 4weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional conservative treatment and therapeutic ultrasound in people with Arteriosclerosis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of ankle brachial ratio at 4 weeks of treatment (time frame: 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.