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The Safety, Efficacy and Tolerability of Remote Ischemic Preconditioning as a Therapy to DMD

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02614820
Enrollment
100
Registered
2015-11-25
Start date
2015-11-30
Completion date
2016-12-31
Last updated
2015-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne Muscular Dystrophy (DMD)

Keywords

Ischemic preconditioning, sefety, efficacy, DMD

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.

Interventions

PROCEDURERemote Ischemic Preconditioning Training Apparatus

Sponsors

General Hospital of Chinese Armed Police Forces
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
2 Years to 6 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frame
Serum CK value0 day
Serum myoglobin values0 day

Secondary

MeasureTime frame
Serum myoglobin values3 months

Other

MeasureTime frame
Serum myoglobin values6 months
6-minute walking test0 day
T2 values0 day

Countries

China

Contacts

Primary Contactwu shiwen, Dr.
wu_shiwen@yahoo.com13910238117

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026