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

November 22, 2015 updated by: General Hospital of Chinese Armed Police Forces

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • BeiJing, China
        • Recruiting
        • Shiwen wu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals
Procedure: Remote Ischemic Preconditioning Training Apparatus
Other: control group
inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals
Procedure: Remote Ischemic Preconditioning Training Apparatus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum CK value
Time Frame: 0 day
0 day
Serum CK value
Time Frame: 3 days
3 days
Serum CK value
Time Frame: 3 months
3 months
Serum CK value
Time Frame: 6 months
6 months
Serum myoglobin values
Time Frame: 0 day
0 day
Serum myoglobin values
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum myoglobin values
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Serum myoglobin values
Time Frame: 6 months
6 months
6-minute walking test
Time Frame: 0 day
0 day
6-minute walking test
Time Frame: 3 days
3 days
6-minute walking test
Time Frame: 3 months
3 months
6-minute walking test
Time Frame: 6 months
6 months
T2 values
Time Frame: 0 day
0 day
T2 values
Time Frame: 3 days
3 days
T2 values
Time Frame: 3 months
3 months
T2 values
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Chinese Armed Police Forces

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 22, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Estimate)

November 25, 2015

Last Update Submitted That Met QC Criteria

November 22, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JZheng

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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