Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-25 @ 5:44 PM
Study NCT ID:
NCT02382302
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2015-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research to Evaluate Efficiency in U-health Solution Service for the Chronic Wound Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-02', 'studyFirstSubmitDate': '2015-02-17', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)', 'timeFrame': '4weeks post-treatment', 'description': '1. Data collection\n\n * The measurement of the size of pressure ulcer\n * Medical examination;the degree of recovery of pressure ulcer\n2. Remote physician monitoring\n\n \\- The patient data was transmitted from the smart-phone to the website via open application programming interface (API)\n3. Prescription\n4. Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.'}], 'secondaryOutcomes': [{'measure': 'Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)', 'timeFrame': '1week post-treatment', 'description': '1. Data collection\n\n * The measurement of the size of pressure ulcer\n * Medical examination;the degree of recovery of pressure ulcer\n2. Remote physician monitoring\n\n \\- The patient data was transmitted from the smart-phone to the website via open application programming interface (API)\n3. Prescription\n4. Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.'}, {'measure': 'Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)', 'timeFrame': '2weeks post-treatment', 'description': '1. Data collection\n\n * The measurement of the size of pressure ulcer\n * Medical examination;the degree of recovery of pressure ulcer\n2. Remote physician monitoring\n\n \\- The patient data was transmitted from the smart-phone to the website via open application programming interface (API)\n3. Prescription\n4. Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.'}, {'measure': 'Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)', 'timeFrame': '3weeks post-treatment', 'description': '1. Data collection\n\n * The measurement of the size of pressure ulcer\n * Medical examination;the degree of recovery of pressure ulcer\n2. Remote physician monitoring\n\n \\- The patient data was transmitted from the smart-phone to the website via open application programming interface (API)\n3. Prescription\n4. Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['U-health', 'chronic wound management'], 'conditions': ['Pressure Ulcer']}, 'descriptionModule': {'briefSummary': 'This trial is a prospective research to evaluate efficiency in U-health solution service based on Mobile for the chronic wound management.', 'detailedDescription': 'This trial conducted to assess the efficiency of teleconsultation using the smart-phone-based store-and-forward system in promoting the wound healing process as well as cost-effectiveness in patients with pressure ulcer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have pressure ulcer\n* Subjects who voluntarily decided the participation of the study and signed the informed consent\n\nExclusion Criteria:\n\n* Subjects who have Osteomyelitis\n* Subjects who have suppuration\n* Subjects who participated in other clinical trial within 30 days from screening date'}, 'identificationModule': {'nctId': 'NCT02382302', 'briefTitle': 'Research to Evaluate Efficiency in U-health Solution Service for the Chronic Wound Management', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Smart Phone-based Tele-consultation System in the Management of Chronic Pressure Ulcer', 'orgStudyIdInfo': {'id': 'E-1106/063-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemedicine system', 'description': 'Telemedicine system', 'interventionNames': ['Device: Telemedicine system']}], 'interventions': [{'name': 'Telemedicine system', 'type': 'DEVICE', 'description': 'The data such as photographs can be collected simply using built-in cameras installed in smart-phones that used the standard touch-screen user interface (UI) and camera installed in the iPhone3GS and iPhone4 using iOS 3.0 and iOS 5.0, respectively. Subjects were instructed to transmit the photographs of the wounds then investigator performed the photography in such a manner that the size of pressure ulcer should be automatically measured based on a 1 cm x 1 cm-sized indicator on the screen.', 'armGroupLabels': ['Telemedicine system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'ChanYeong Heo, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chan-Yeong Heo', 'class': 'OTHER'}, 'collaborators': [{'name': 'KT Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Chan-Yeong Heo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}