Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-03-31 @ 10:53 AM
Study NCT ID:
NCT06432335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E-Socket, Diagnostic Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anterior-Distal Limb Motion', 'timeFrame': '12 months', 'description': 'Monitor anterior-distal limb motion in the prosthesis to determine if limb motions and activity changes precede changes in limb health. Interviews with the participants and questionnaires will be used to assess the outcome measure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trans-Tibial Amputation']}, 'descriptionModule': {'briefSummary': 'The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3).\n\nAim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants\' own clinicians.\n\nNote: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nProsthesis Users:\n\nAims 1 and 2\n\n* Over 18 years of age\n* Unilateral or bilateral trans-tibial amputation at least 12 months prior\n* Have a limb of length 9 cm or greater\n* Are capable of at least 5 minutes of continuous walking\n* Regularly use a definitive prosthesis\n* Do not regularly use assistive devices (e.g., cane, walker) for ambulation\n* Do not have open wounds on their residual limb at the time of enrollment\n\nAim 2\n\n-Regularly visit their prosthetist at least twice a year,\n\nExclusion Criteria:\n\n\\-\n\nProsthesis Users:\n\nAims 1 and 2\n\n* Reduced skin sensation\n* Presence of skin breakdown\n* Regular use of an assistive device\n* Persons with trans-femoral amputation\n\nAim 1 Only\n\n-Vacuum suspension users'}, 'identificationModule': {'nctId': 'NCT06432335', 'briefTitle': 'E-Socket, Diagnostic Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'E-Socket, Diagnostic Monitoring', 'orgStudyIdInfo': {'id': 'STUDY00016676'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'E-Socket Monitoring', 'interventionNames': ['Other: E-Socket Monitoring']}], 'interventions': [{'name': 'E-Socket Monitoring', 'type': 'OTHER', 'description': 'Limb-socket motion data is collected during participant take-home use. Bimonthly telephone interviews are conducted to assess participant residual limb health status. Analysis is conducted to determine if limb motions and activity changes precede limb health changes.', 'armGroupLabels': ['E-Socket Monitoring']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nick McCarthy', 'role': 'CONTACT', 'email': 'nickmcc@uw.edu', 'phone': '206-616-9148'}], 'overallOfficials': [{'name': 'Joan Sanders', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Joan E Sanders', 'investigatorAffiliation': 'University of Washington'}}}}