Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-09 @ 2:15 AM
Study NCT ID:
NCT02614820
Status:
UNKNOWN
Last Update Posted:
2015-11-25
First Post:
2015-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety, Efficacy and Tolerability of Remote Ischemic Preconditioning as a Therapy to DMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-22', 'studyFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2015-11-22', 'lastUpdatePostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum myoglobin values', 'timeFrame': '6 months'}, {'measure': '6-minute walking test', 'timeFrame': '0 day'}, {'measure': '6-minute walking test', 'timeFrame': '3 days'}, {'measure': '6-minute walking test', 'timeFrame': '3 months'}, {'measure': '6-minute walking test', 'timeFrame': '6 months'}, {'measure': 'T2 values', 'timeFrame': '0 day'}, {'measure': 'T2 values', 'timeFrame': '3 days'}, {'measure': 'T2 values', 'timeFrame': '3 months'}, {'measure': 'T2 values', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'Serum CK value', 'timeFrame': '0 day'}, {'measure': 'Serum CK value', 'timeFrame': '3 days'}, {'measure': 'Serum CK value', 'timeFrame': '3 months'}, {'measure': 'Serum CK value', 'timeFrame': '6 months'}, {'measure': 'Serum myoglobin values', 'timeFrame': '0 day'}, {'measure': 'Serum myoglobin values', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'Serum myoglobin values', 'timeFrame': '3 months'}]}, 'conditionsModule': {'keywords': ['Ischemic preconditioning', 'sefety', 'efficacy', 'DMD'], 'conditions': ['Duchenne Muscular Dystrophy (DMD)']}, 'descriptionModule': {'briefSummary': "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.\n\nMethods: 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.\n\nPurpose：\n\n1. To evaluate the safety and tolerability of remote ischemic preconditioning for DMD patients\n2. To identify the effectiveness of remote ischemic preconditioning for DMD patients."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Genetic analysis of DMD; from 2 to 6 years old ;without other diseases .\n\n\\-\n\nExclusion Criteria: other congenital diseases;upper respiratory infection, gastroenteritis, vaccination, trauma.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02614820', 'briefTitle': 'The Safety, Efficacy and Tolerability of Remote Ischemic Preconditioning as a Therapy to DMD', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Chinese Armed Police Forces'}, 'orgStudyIdInfo': {'id': 'JZheng'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'description': 'inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals', 'interventionNames': ['Procedure: Remote Ischemic Preconditioning Training Apparatus']}, {'type': 'OTHER', 'label': 'control group', 'description': 'inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals', 'interventionNames': ['Procedure: Remote Ischemic Preconditioning Training Apparatus']}], 'interventions': [{'name': 'Remote Ischemic Preconditioning Training Apparatus', 'type': 'PROCEDURE', 'armGroupLabels': ['control group', 'treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wu shiwen, Dr.', 'role': 'CONTACT', 'email': 'wu_shiwen@yahoo.com', 'phone': '13910238117'}], 'facility': 'Shiwen wu', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'wu shiwen, Dr.', 'role': 'CONTACT', 'email': 'wu_shiwen@yahoo.com', 'phone': '13910238117'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Chinese Armed Police Forces', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}