The Safety, Efficacy and Tolerability of Remote Ischemic Preconditioning as a Therapy to DMD
1 other identifier
interventional
100
1 country
1
Brief 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. 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：
- 1.To evaluate the safety and tolerability of remote ischemic preconditioning for DMD patients
- 2.To identify the effectiveness of remote ischemic preconditioning for DMD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 17, 2015
CompletedFirst Posted
Study publicly available on registry
November 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 25, 2015
November 1, 2015
8 months
November 17, 2015
November 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Serum CK value
0 day
Serum CK value
3 days
Serum CK value
3 months
Serum CK value
6 months
Serum myoglobin values
0 day
Serum myoglobin values
3 days
Secondary Outcomes (1)
Serum myoglobin values
3 months
Other Outcomes (9)
Serum myoglobin values
6 months
6-minute walking test
0 day
6-minute walking test
3 days
- +6 more other outcomes
Study Arms (2)
treatment group
EXPERIMENTALinflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals
control group
OTHERinflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shiwen wu
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2015
First Posted
November 25, 2015
Study Start
November 1, 2015
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
November 25, 2015
Record last verified: 2015-11