Duchenne Muscular Dystrophy (DMD)NCT02614820
The Safety, Efficacy and Tolerability of Remote Ischemic Preconditioning as a Therapy to DMD
A study testing Remote Ischemic Preconditioning Training Apparatus in people with Duchenne Muscular Dystrophy (DMD), run by General Hospital of Chinese Armed Police Forces at 1 site in China.
Trial summary
Background: Duchenne muscular dystrophy (DMD) is an X chromosome recessive hereditary disease and mainly characterized by progressive muscle weakness and atrophy. Glucocorticoid is the only proven effective medicine,while side effects limit its use. Read more about this study
- Who is it for?
- Ages 2 to 6 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- Remote Ischemic Preconditioning Training Apparatus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2016
- 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 2 to 6 years
- Men only
- No healthy volunteers
- Child
Inclusion Criteria:Genetic analysis of DMD; from 2 to 6 years old ;without other diseases .
-
Exclusion Criteria: other congenital diseases;upper respiratory infection, gastroenteritis, vaccination, trauma.
-
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shiwen wu
Beijing
wu shiwen, Dr., 13910238117, wu_shiwen@yahoo.com
About this study
Background: Duchenne muscular dystrophy (DMD) is an X chromosome recessive hereditary disease and mainly characterized by progressive muscle weakness and atrophy. Glucocorticoid is the only proven effective medicine,while side effects limit its use. Recent studies have shown that the vascular density in the DMD patients' muscle is decreased,so muscle are in ischemic and anoxic. Remote ischemic preconditioning(RIPC) can improve the capable of resistanting ischemia and hypoxia and maybe a potential therapy for DMD patients.
Methods: 100 patients (aged 2 to 6 years)will be divided into two groups(treatment and control groups) randomly. Treatment group will receive an RIPC stimulus (inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals) while control group will receive a similar stimulus (inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals). Serum kinase level ,Blood levels of myoglobin, Evaluation of motor function(Four steps test;6-minute walking test) and MRI of lower limbs）at 0 days, 3 days, 3months ,6months.
Read more
Purpose：
- To evaluate the safety and tolerability of remote ischemic preconditioning for DMD patients
- To identify the effectiveness of remote ischemic preconditioning for DMD patients.
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- Remote Ischemic Preconditioning Training Apparatus
- Keywords
- Ischemic preconditioning, sefety, efficacy, DMD
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Preconditioning Training ApparatusProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals Receives: Procedure: Remote Ischemic Preconditioning Training Apparatus |
| control group | Other | inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals Receives: Procedure: Remote Ischemic Preconditioning Training Apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CK value
Measured: 0 day
Serum CK value
Measured: 3 days
Serum CK value
Measured: 3 months
Serum CK value
Measured: 6 months
Serum myoglobin values
Measured: 0 day
Serum myoglobin values
Measured: 3 days
Secondary outcomes (1)
Serum myoglobin values
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Chinese Armed Police Forces
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614820
- Sponsor's protocol ID
- JZheng
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Efficacy and Tolerability of Remote Ischemic Preconditioning as a Therapy to DMD
- ClinicalTrials.gov ID
- NCT02614820
- Acronym / sponsor ID
- JZheng
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Keywords
- Ischemic preconditioning, sefety, efficacy, DMD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Nov 2015 (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.
Background: Duchenne muscular dystrophy (DMD) is an X chromosome recessive hereditary disease and mainly characterized by progressive muscle weakness and atrophy. Glucocorticoid is the only proven effective medicine,while side effects limit its use. Recent studies have shown that the vascular density in the DMD patients' muscle is decreased,so muscle are in ischemic and anoxic. Remote ischemic preconditioning(RIPC) can improve the capable of resistanting ischemia and hypoxia and maybe a potential therapy for DMD patients.
Methods: 100 patients (aged 2 to 6 years)will be divided into two groups(treatment and control groups) randomly. Treatment group will receive an RIPC stimulus (inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals) while control group will receive a similar stimulus (inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals). Serum kinase level ,Blood levels of myoglobin, Evaluation of motor function(Four steps test;6-minute walking test) and MRI of lower limbs）at 0 days, 3 days, 3months ,6months.
Purpose：
- To evaluate the safety and tolerability of remote ischemic preconditioning for DMD patients
- To identify the effectiveness of remote ischemic preconditioning for DMD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Procedure: Remote Ischemic Preconditioning Training Apparatusinflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals |
| control group | Other | Procedure: Remote Ischemic Preconditioning Training Apparatusinflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Remote Ischemic Preconditioning Training Apparatus | Procedure or surgery | control group, treatment group |
Primary outcome
Serum CK value
Time frame: 0 day
Serum CK value
Time frame: 3 days
Serum CK value
Time frame: 3 months
Serum CK value
Time frame: 6 months
Serum myoglobin values
Time frame: 0 day
Serum myoglobin values
Time frame: 3 days
1 secondary outcome
Serum myoglobin values
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Preconditioning Training Apparatus in people with Duchenne Muscular Dystrophy (DMD), run by General Hospital of Chinese Armed Police Forces at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact wu shiwen, Dr. (13910238117, wu_shiwen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum CK value (time frame: 0 day). The study lists 6 primary outcomes in all. 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 25 Nov 2015.