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

NCT ID: NCT02614820

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Duchenne Muscular Dystrophy (DMD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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treatment group

inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals

Group Type EXPERIMENTAL

Remote Ischemic Preconditioning Training Apparatus

Intervention Type PROCEDURE

control group

inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals

Group Type OTHER

Remote Ischemic Preconditioning Training Apparatus

Intervention Type PROCEDURE

Interventions

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Remote Ischemic Preconditioning Training Apparatus

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Chinese Armed Police Forces

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shiwen wu

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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wu shiwen, Dr.

Role: CONTACT

13910238117

Facility Contacts

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wu shiwen, Dr.

Role: primary

13910238117

Other Identifiers

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JZheng

Identifier Type: -

Identifier Source: org_study_id