Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-20 @ 12:37 PM
Study NCT ID:
NCT02317835
Status:
COMPLETED
Last Update Posted:
2016-06-09
First Post:
2014-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetic Foot Ulcer Prevention System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-08', 'studyFirstSubmitDate': '2014-12-10', 'studyFirstSubmitQcDate': '2014-12-15', 'lastUpdatePostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of hot spots on a foot thermal map image', 'timeFrame': '9 months'}]}, 'conditionsModule': {'conditions': ['Diabetic Foot']}, 'referencesModule': {'references': [{'pmid': '29854007', 'type': 'DERIVED', 'citation': 'Petrova NL, Whittam A, MacDonald A, Ainarkar S, Donaldson AN, Bevans J, Allen J, Plassmann P, Kluwe B, Ring F, Rogers L, Simpson R, Machin G, Edmonds ME. Reliability of a novel thermal imaging system for temperature assessment of healthy feet. J Foot Ankle Res. 2018 May 30;11:22. doi: 10.1186/s13047-018-0266-1. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 years or older\n2. Has no history of diabetes\n3. Has no previous history of foot ulceration\n4. Has no previous history of foot surgery\n5. Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)\n6. Has no history of peripheral neuropathy\n7. Has no history of peripheral arterial disease\n8. Must be able to provide meaningful written informed consent for the study\n\nExclusion Criteria:\n\n1. Has active foot ulceration and infection\n2. Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study\n3. Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study\n4. Has an implantable electronic device\n5. Is aged \\<18'}, 'identificationModule': {'nctId': 'NCT02317835', 'acronym': 'DFUPS', 'briefTitle': 'Diabetic Foot Ulcer Prevention System', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'An Innovative System for the Early Identification, Monitoring, Evaluation and Diagnosis of Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'version 2 (02/3/2015)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study in healthy volunteers', 'description': 'Skin foot temperature measurement by DFUPS device', 'interventionNames': ['Device: DFUPS']}], 'interventions': [{'name': 'DFUPS', 'type': 'DEVICE', 'description': 'The DFUPS device is a two-camera instrument for capturing images of feet', 'armGroupLabels': ['Study in healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M9 4BE', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Pennine Acute Hospitals NHS Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE3 3HD', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'The Newcastle upon Tyne Hospitals', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Physical Laboratory', 'class': 'OTHER'}, {'name': 'University of South Wales', 'class': 'OTHER'}, {'name': 'Freeman Health System', 'class': 'OTHER'}, {'name': 'Pennine Acute Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Photometrix', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}