Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-25 @ 11:07 PM
Study NCT ID:
NCT01870934
Status:
UNKNOWN
Last Update Posted:
2013-10-29
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Camera - Telemedical Foot Ulcer Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D016523', 'term': 'Foot Ulcer'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of 3D image and normal assessment of wounds', 'timeFrame': 'outcome measure is assessed in 2013'}], 'secondaryOutcomes': [{'measure': 'Comparison of 3D and 2D image assessment of wounds', 'timeFrame': 'november 2013'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Telemedicine', 'Diabetes', 'Foot Ulcers'], 'conditions': ['Diabetes Mellitus', 'Foot Ulcers']}, 'descriptionModule': {'briefSummary': 'Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel.\n\nThe 3D photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. The camera was developed in close cooperation with TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic foot ulcers patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diabetic foot ulcers, which has been the diagnosis, stratification (eg ischemia, neuropathy, etc.) and treatment according to current guidelines refer "Diabetic Foot Study Group". Age 18-90 years\n\nExclusion Criteria:\n\n* Superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)'}, 'identificationModule': {'nctId': 'NCT01870934', 'briefTitle': '3D Camera - Telemedical Foot Ulcer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'A Feasibility Study on the Development of 3D Optic Ulcer Camera', 'orgStudyIdInfo': {'id': 'OUH3D01'}, 'secondaryIdInfos': [{'id': '12-08-00621', 'type': 'OTHER', 'domain': 'CIV-ID'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Telemedicine, Diabetes, foot ulcer', 'interventionNames': ['Device: Camera']}], 'interventions': [{'name': 'Camera', 'type': 'DEVICE', 'description': 'No real intervention, but a comparison of different methods including the new medical device 3D camera.', 'armGroupLabels': ['Telemedicine, Diabetes, foot ulcer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Benjamin Sc Rasmussen, M.D.', 'role': 'CONTACT', 'email': 'benjamin.rasmussen@ouh.regionsyddanmark.dk'}, {'name': 'Knud Yderstræde, M.D, Phd.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Benjamin Sc Rasmussen, M.D.', 'role': 'CONTACT', 'email': 'bsr@rsyd.dk'}, {'name': 'Benjamin Schnack Sc Rasmussen', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Benjamin Schnack Rasmussen, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hosptial'}, {'name': 'Knud Yderstræde, MD, Ph.d.', 'role': 'STUDY_CHAIR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research responsible Chief Surgeon', 'investigatorFullName': 'Johnny Froekjaer', 'investigatorAffiliation': 'Odense University Hospital'}}}}