Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-31 @ 11:56 AM
Study NCT ID:
NCT02102958
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2014-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nonvisual Foot Examination for People With Diabetes and Visual Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D014786', 'term': 'Vision Disorders'}], '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': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2014-03-31', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total new foot problems', 'timeFrame': '6 months', 'description': 'total number of foot problems documented by the podiatrist at podiatry visit'}], 'primaryOutcomes': [{'measure': 'Frequency of foot examination at home', 'timeFrame': '6 months', 'description': "number of times that the enrolled participant or someone else examined the person's feet at home during the study period"}], 'secondaryOutcomes': [{'measure': 'New foot problems discovered at home', 'timeFrame': '6 months', 'description': "total number of new foot problems reported to podiatrists as having been discovered at home by the participant or someone else examining the person's feet"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes', 'visual impairment', 'foot care', 'diabetes self-management education'], 'conditions': ['Diabetes', 'Visual Impairment']}, 'descriptionModule': {'briefSummary': "Because people who have both diabetes and visual impairment have high risk for foot problems, prevention of ulcers and amputation is a high priority. Usual care in diabetes self-management education (DSME) is to teach them to seek sighted assistance for regular foot examination, yet clinical experience suggests that this advice is seldom heeded. One possible solution is to teach use of the nonvisual senses of touch and smell for a systematic, thorough foot self-examination. The purpose of this pilot study was to compare the efficacy, acceptability, and feasibility of nonvisual foot examination with usual care (examination of the visually impaired person's feet by a sighted family member or friend)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over age 18\n* diagnosed with either type 1 or type 2 diabetes\n* stated they had visual impairment\n\nExclusion Criteria:\n\n* unable to pass a brief decisional capacity test\n* had a score above 80 on the near vision scale of the National Eye Institute Visual Functioning Questionnaire\n* had bilateral lower extremity amputations\n* by self-report were unable to sense light touch on two or more fingers or either hand'}, 'identificationModule': {'nctId': 'NCT02102958', 'briefTitle': 'Nonvisual Foot Examination for People With Diabetes and Visual Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Nonvisual Foot Examination for People With Diabetes and Visual Impairment', 'orgStudyIdInfo': {'id': 'R21NR012513', 'link': 'https://reporter.nih.gov/quickSearch/R21NR012513', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'DSME with Nonvisual Foot Examination', 'interventionNames': ['Behavioral: DSME with Nonvisual Foot Examination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison', 'description': 'DSME with Usual Foot Examination Instruction', 'interventionNames': ['Behavioral: DSME with Usual Foot Examination Instruction']}], 'interventions': [{'name': 'DSME with Nonvisual Foot Examination', 'type': 'BEHAVIORAL', 'description': 'Diabetes Self-Management Education (DSME) with Nonvisual Foot Examination included comprehensive DSME taught by Certified Diabetes Educators that included instruction in nonvisual self-examination of feet using the senses of touch and smell.', 'armGroupLabels': ['Experimental']}, {'name': 'DSME with Usual Foot Examination Instruction', 'type': 'BEHAVIORAL', 'description': 'DSME with usual foot examination instruction was comprehensive diabetes self management education taught by Certified Diabetes Educators that included usual care instructions for examination for feet at home by visually impaired persons, i.e., to have a sighted person check the feet regularly.', 'armGroupLabels': ['Comparison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Ann S Williams, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}