Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-01 @ 5:17 PM
Study NCT ID:
NCT03088566
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of the D-Foot at the Department of Prosthetics and Orthotics
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The randomisation will be determined by sequencing patients into on of the two groups following the grouping found in closed envelopes.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled study. One group will be foot screened following the routine described in the web program, the D-Foot. The other group will be foot screened by the use of conventional methods.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2017-03-16', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients reported experience measure (PREM)', 'timeFrame': 'one month', 'description': 'Orthotic and Prosthetic Users survey will be used to evaluate if the PREM scores are higher in the group that was foot screened following the D-Foot method. MEASURE is scored to range from 0 (the lowest possible score) to 100 (the highest possible score).'}, {'measure': 'Patients reported experience measure (PREM)', 'timeFrame': 'one month', 'description': 'A selection of questions from the Swedish national patient survey will be used to evaluate if the PREM scores are higher in the group that was foot screened following the D-Foot method'}], 'secondaryOutcomes': [{'measure': 'PREM', 'timeFrame': 'one month', 'description': 'The system usability scale will be used to calculate the level of usability among the patients that were randomized to the D-Foot group'}, {'measure': 'Patients reported outcome measure (PROM)', 'timeFrame': 'one month', 'description': 'The answers from the EQ-5D will be used to describe the health related quality of life of the study participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Foot']}, 'referencesModule': {'references': [{'pmid': '39533310', 'type': 'DERIVED', 'citation': 'Hellstrand Tang U, Tranberg R, Sundberg L, Scandurra I. How do patients and healthcare professionals experience foot examinations in diabetes care? - A randomised controlled study of digital foot examinations versus traditional foot examinations. BMC Health Serv Res. 2024 Nov 12;24(1):1387. doi: 10.1186/s12913-024-11674-w.'}]}, 'descriptionModule': {'briefSummary': 'Early identification of potential risk factors for the onset of diabetic foot ulcers are recommended. However, in a Swedish context, there has been no standardised routines to be used in the foot screening procedure. In this study a new standardised routine, the D-Foot, will be tested at the Department of Prosthetics and Orthotics. The usability of the web program will be tested.', 'detailedDescription': 'The primary research questions are"how do patients with diabetes perceive the foot screening?" and "do the perception differ in the group that was foot screened by the use of the D-Foot compared to the group that was foot screened with conventional methods?"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes\n* patients referred to the Department of Prosthetics and Orthotics at Sahlgrenska University Hospital with the aim to be provided with assistive devices with the purpose to protect the feet from foot ulcers\n* be able to read and understand the Swedish language\n\nExclusion Criteria:\n\n\\*being unable to read and understand the Swedish language'}, 'identificationModule': {'nctId': 'NCT03088566', 'briefTitle': 'Implementation of the D-Foot at the Department of Prosthetics and Orthotics', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Implementation of the D-Foot at the Department of Prosthetics and Orthotics', 'orgStudyIdInfo': {'id': '224651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The D-Foot method', 'description': 'The patients are being foot screened following the routine that is programmed in the D-Foot.', 'interventionNames': ['Procedure: The D-Foot method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional foot screening', 'description': 'The patients are being foot screened according to conventional methods.', 'interventionNames': ['Procedure: Conventional foot screening']}], 'interventions': [{'name': 'The D-Foot method', 'type': 'PROCEDURE', 'description': 'The D-Foot method is a standardised routine of foot screening. The D-Foot i web program aimed to be used on a surf plate.', 'armGroupLabels': ['The D-Foot method']}, {'name': 'Conventional foot screening', 'type': 'PROCEDURE', 'description': 'The foot screening is performed with clinical conventional methods.', 'armGroupLabels': ['Conventional foot screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41285', 'city': 'Gothenburg', 'state': 'Region Västragötaland', 'country': 'Sweden', 'facility': 'Department of Prostetics & Orthotics', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Certified prosthetist and orthotist', 'investigatorFullName': 'Ulla Hellstrand Tang', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}