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

Duchenne Muscular Dystrophy (DMD) Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02614820
• Other study ID #: JZheng
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2015
• Last updated: November 22, 2015
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: General Hospital of Chinese Armed Police Forces
• Contact: wu shiwen, Dr.
• Phone: 13910238117
• Email: wu_shiwen[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy (DMD)
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Procedure:
• Remote Ischemic Preconditioning Training Apparatus

Locations

Country	Name	City	State
China	Shiwen wu	BeiJing

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum myoglobin values		6 months	Yes
Other	6-minute walking test		0 day	Yes
Other	6-minute walking test		3 days	Yes
Other	6-minute walking test		3 months	Yes
Other	6-minute walking test		6 months	Yes
Other	T2 values		0 day	Yes
Other	T2 values		3 days	Yes
Other	T2 values		3 months	Yes
Other	T2 values		6 months	Yes
Primary	Serum CK value		0 day	Yes
Primary	Serum CK value		3 days	Yes
Primary	Serum CK value		3 months	Yes
Primary	Serum CK value		6 months	Yes
Primary	Serum myoglobin values		0 day	Yes
Primary	Serum myoglobin values		3 days	Yes
Secondary	Serum myoglobin values		3 months	Yes