Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT05341427
Status:
UNKNOWN
Last Update Posted:
2022-06-03
First Post:
2022-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2022-04-17', 'studyFirstSubmitQcDate': '2022-04-17', 'lastUpdatePostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound healing rate', 'timeFrame': 'maximum of 6 weeks', 'description': 'tools for assessment of wound area changes before and after treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burn Wound']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to pulsed electromagnetic therapy in burn patients", 'detailedDescription': "It will be hypothesized that\n\n1. Age may significantly affect burn wound healing's response to pulsed electromagnetic waves.\n2. TBSA may significantly affect burn wound healing's response to pulsed electromagnetic waves\n3. Depth of wound may significantly affect burn wound healing's response to pulsed electromagnetic waves\n4. Wound healing stage may significantly affect burn wound healing's response to pulsed electromagnetic waves This study will be conducted at the in-patient burn units. There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units.\n\nPulsed electromagnetic waves will be performed for 60 min 3 times per week till healing (maximum 8 weeks) on the wound area.\n\nPEMF therapy will be as (duration: 60 minutes; frequency: 12 Hz; intensity: 12 Gauss)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Partial thickness Burn wound depth. Age ranges from 20-50 years. TBSA more than 15% Sufficient understanding to perform the tests. Exclusion Criteria Diabetic patients. Patients receiving immunosuppressive drugs. Associated co-morbidities, such as neurological diseases, malnutrition, and other inflammatory and/or infectious diseases.'}, 'identificationModule': {'nctId': 'NCT05341427', 'briefTitle': 'DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'burn wound receiving electromagnetic therapy', 'description': 'There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units of Cairo university hospitals', 'interventionNames': ['Device: electromagnetic device']}], 'interventions': [{'name': 'electromagnetic device', 'type': 'DEVICE', 'description': 'electromagnetic waves for burn wound', 'armGroupLabels': ['burn wound receiving electromagnetic therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy for surgery- cairo university', 'investigatorFullName': 'ahmed mohamed nagy', 'investigatorAffiliation': 'Cairo University'}}}}