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

Primary Purpose

Duchenne Muscular Dystrophy (DMD)

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning Training Apparatus
Sponsored by
General Hospital of Chinese Armed Police Forces
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Duchenne Muscular Dystrophy (DMD) focused on measuring Ischemic preconditioning, sefety, efficacy, DMD

Eligibility Criteria

2 Years - 6 Years (Child)MaleDoes not accept healthy volunteers

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.

-

Sites / Locations

  • Shiwen wuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

treatment group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Serum CK value
Serum CK value
Serum CK value
Serum CK value
Serum myoglobin values
Serum myoglobin values

Secondary Outcome Measures

Serum myoglobin values

Full Information

First Posted
November 17, 2015
Last Updated
November 22, 2015
Sponsor
General Hospital of Chinese Armed Police Forces
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1. Study Identification

Unique Protocol Identification Number
NCT02614820
Brief Title
The Safety, Efficacy and Tolerability of Remote Ischemic Preconditioning as a Therapy to DMD
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Chinese Armed Police Forces

4. Oversight

5. Study Description

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: To evaluate the safety and tolerability of remote ischemic preconditioning for DMD patients To identify the effectiveness of remote ischemic preconditioning for DMD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy (DMD)
Keywords
Ischemic preconditioning, sefety, efficacy, DMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals
Arm Title
control group
Arm Type
Other
Arm Description
inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Preconditioning Training Apparatus
Primary Outcome Measure Information:
Title
Serum CK value
Time Frame
0 day
Title
Serum CK value
Time Frame
3 days
Title
Serum CK value
Time Frame
3 months
Title
Serum CK value
Time Frame
6 months
Title
Serum myoglobin values
Time Frame
0 day
Title
Serum myoglobin values
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Serum myoglobin values
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Serum myoglobin values
Time Frame
6 months
Title
6-minute walking test
Time Frame
0 day
Title
6-minute walking test
Time Frame
3 days
Title
6-minute walking test
Time Frame
3 months
Title
6-minute walking test
Time Frame
6 months
Title
T2 values
Time Frame
0 day
Title
T2 values
Time Frame
3 days
Title
T2 values
Time Frame
3 months
Title
T2 values
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wu shiwen, Dr.
Phone
13910238117
Email
wu_shiwen@yahoo.com
Facility Information:
Facility Name
Shiwen wu
City
BeiJing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wu shiwen, Dr.
Phone
13910238117
Email
wu_shiwen@yahoo.com

12. IPD Sharing Statement

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

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