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Status unknownNCT02614820Updated Nov 25, 2015

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

An interventional study of Remote Ischemic Preconditioning Training Apparatus in Duchenne Muscular Dystrophy (DMD), sponsored by General Hospital of Chinese Armed Police Forces. Status unknown at 1 site in China. Open to male participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2015-11-25.

Sponsored by General Hospital of Chinese Armed Police Forces · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
2 Years to 6 Years
Sex
Male
01

Study 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.
02

Conditions studied

  • Duchenne Muscular Dystrophy (DMD)

Keywords

  • Ischemic preconditioning
  • sefety
  • efficacy
  • DMD
03

In context

Muscular Dystrophies

548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.

This study's planned enrollment of 100 is above the median of 24 across 344 interventional studies indexed under Muscular Dystrophies.

Browse Muscular Dystrophies studies →

Lead sponsor

General Hospital of Chinese Armed Police Forces is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 6 Years
Sexes eligible
Male
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.

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureRemote Ischemic Preconditioning Training Apparatus
06

What researchers measure

Primary outcomes

  1. Serum CK value

    Time frame: 0 day

  2. Serum CK value

    Time frame: 3 days

  3. Serum CK value

    Time frame: 3 months

  4. Serum CK value

    Time frame: 6 months

  5. Serum myoglobin values

    Time frame: 0 day

  6. Serum myoglobin values

    Time frame: 3 days

Secondary outcomes

  1. Serum myoglobin values

    Time frame: 3 months

Other outcomes

  1. Serum myoglobin values

    Time frame: 6 months

  2. 6-minute walking test

    Time frame: 0 day

  3. 6-minute walking test

    Time frame: 3 days

  4. 6-minute walking test

    Time frame: 3 months

  5. 6-minute walking test

    Time frame: 6 months

  6. T2 values

    Time frame: 0 day

  7. T2 values

    Time frame: 3 days

  8. T2 values

    Time frame: 3 months

  9. T2 values

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Shiwen wu
    BeiJing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02614820
Lead sponsor
General Hospital of Chinese Armed Police Forces
Responsible party
Sponsor
First posted
Nov 25, 2015
Start date
Nov 2015
Primary completion
Jul 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Nov 25, 2015

Study contacts

wu shiwen, Dr.
Contact
wu_shiwen@yahoo.com
13910238117
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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