Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT06200532
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2023-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FOOTSAK (Footwear Self-Assessment Kit)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy', 'timeFrame': 'Visit 1 on day 1', 'description': "Accuracy: average (mean) variation of study participants' foot and footwear measurements from a trained researcher's measurements and standard error of measurements."}, {'measure': 'Reliability', 'timeFrame': 'Visit 1 on day 1', 'description': 'Intrarater reliability (Intraclass Correlation Coefficient) based on four measurements of the feet and footwear by study participants'}, {'measure': 'Ease of use scores', 'timeFrame': 'Visit 1 on day 1', 'description': 'Mean ease of use visual analogue scores (i) both overall and for each section of instructional material; (ii) for each study video / demonstration and overall; and (iii) both overall and for each measuring tools included within the FOOTSAK'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '40518605', 'type': 'DERIVED', 'citation': 'Jones PJ, Bullock J, Weaving L, Davies MJ, Razieh C, Ahmad E. Effectiveness of diabetes footwear fit assessment by people with diabetes and their family or partners: A reliability study. Diabet Med. 2025 Aug;42(8):e70065. doi: 10.1111/dme.70065. Epub 2025 Jun 15.'}]}, 'descriptionModule': {'briefSummary': "FOOTSAK is a Footwear Self-Assessment Kit intended to empower people with diabetes by providing the necessary tools and instructional materials to enable self-assessment to determine whether footwear has adequate length and width. This feasibility study aims to determine whether people with diabetes and their footwear buddies can use FOOTSAK with sufficient (1) accuracy, (2) reliability and (3) ease of use to identify incorrectly fitting footwear (IFF).\n\nTen people with type 1 or 2 diabetes without any minor or major toe or foot amputation will be recruited to use the FOOTSAK. Given that foot measurements have to be made whilst standing (to ensure full blood flow to feet during measurements), ten 'Footwear buddies' - will also be recruited. These are people with or without diabetes willing to measure the feet of participating people with diabetes (for example, a spouse, partner, carer, friend, neighbour, or housemate).\n\nBoth participants are asked to watch instructional videos/short demonstrations and read large text instructions. Footwear buddies are asked to repeatedly measure the feet of people with diabetes. People with diabetes are asked to repeatedly measure their footwear then assess whether they are correctly fitting. The feet and footwear of participants with diabetes are then measured by a trained researcher to determine accuracy.\n\n1. Determine whether foot measurements made by footwear buddies are accurate: +/- up to 5mm when compared to a trained researcher.\n2. Determine whether repeated footwear and foot measurements made by participants are reliable: Intraclass Correlation Coefficient ≥0.83 for footwear length and ≥0.72 for footwear width (assuming a 15% decrease in reliability when compared to a trained researchers' scores).\n3. Determine whether FOOTSAK measuring tools and instructional materials ease of use ≥7.0 /10.0 using Visual Analogue Score with free text comments. Any measuring tool failing to obtain a score of 7.0 or higher will be replaced in consultation with PPI participants and any instructional tool amended through PPI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "1. People with type 1 or type 2 diabetes; with or without neuropathy; with or without a history of ulceration who have not had a minor or major amputation;\n2. 'Footwear buddies' who consist of people with or without diabetes who are willing to measure the feet of participating people with diabetes - for example, a spouse, partner, carer, friend, neighbour, or housemate.\n\nInclusion criteria for participant type (1)\n\n1. people who self-report as having type 1 or type 2 diabetes;\n2. aged 18 years or over\n3. without minor or major amputation\n4. Without significant foot deformity\n5. Able to read and understand English\n6. Willingness and capacity to participate in the study and to sign the informed consent form\n\nInclusion criteria for participant type (2)\n\n1. Aged 18 or over\n2. Willing to act as a 'footwear buddy' for a person with diabetes\n3. Able to read and understand English\n4. with a willingness and capacity to participate in the study and to sign the informed consent form\n\nExclusion criteria for participant type (1)\n\n1. Does not self-report as having diabetes (either type 1 or 2)\n2. Not aged 18 or over\n3. Has minor or major amputation\n4. Has significant foot deformity\n5. Unable to read and understand English\n6. Unwilling or lacking capacity to participate\n\nExclusion criteria for participant type (2)\n\n1. Not aged 18 or over\n2. Unwilling to act as a 'footwear buddy' for a person with diabetes\n3. Unable to read and understand English\n4. Unwilling or lacking capacity to participate in the study"}, 'identificationModule': {'nctId': 'NCT06200532', 'briefTitle': 'FOOTSAK (Footwear Self-Assessment Kit)', 'organization': {'class': 'OTHER', 'fullName': 'University of Leicester'}, 'officialTitle': 'Footwear Self-Assessment Kit for People With Diabetes at Risk of Ulceration - A Feasibility Study', 'orgStudyIdInfo': {'id': '0947'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single cohort of people using home footwear self-assessment kit', 'description': "FOOTSAK is a Footwear Self-Assessment Kit intended to empower people with diabetes by providing the necessary tools and instructional materials to enable self-assessment to determine whether footwear has adequate length and width. This feasibility study aims to determine whether people with diabetes and their footwear buddies can use FOOTSAK with sufficient (1) accuracy, (2) reliability and (3) ease of use to identify incorrectly fitting footwear (IFF).\n\nWe will recruit ten people with type 1 or 2 diabetes without any minor or major toe or foot amputation to use the FOOTSAK. Given that foot measurements have to be made whilst standing (to ensure full blood flow to feet during measurements), we will also recruit ten 'Footwear buddies' - people with or without diabetes willing to measure the feet of participating people with diabetes (for example, a spouse, partner, carer, friend, neighbour, or housemate).", 'interventionNames': ['Other: FOOTSAK (FOOTwear self-assessment kit)']}], 'interventions': [{'name': 'FOOTSAK (FOOTwear self-assessment kit)', 'type': 'OTHER', 'description': 'FOOTSAK is a Footwear Self-Assessment Kit intended to empower people with diabetes by providing the necessary tools and instructional materials to enable self-assessment to determine whether footwear has adequate length and width. It includes measuring tools (an internal footwear length gauge, scale dividers for measuring internal footwear width, a slide rule for measuring foot length and width, a ruler and magnifying glass for reading off measurements) and instructional materials (booklet instructions and video materials)', 'armGroupLabels': ['Single cohort of people using home footwear self-assessment kit']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE5 4PW', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Diabetes Research Centre', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leicester', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospitals, Leicester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}