Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-27 @ 1:28 AM
Study NCT ID:
NCT01245504
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2010-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Socket Shapes Made by Central Fabrication Facilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-24', 'studyFirstSubmitDate': '2010-11-18', 'studyFirstSubmitQcDate': '2010-11-19', 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Limb volume', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Limb shape', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['People With Lower Limb Amputation That Are Ambulatory']}, 'descriptionModule': {'briefSummary': 'Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may require more work by prosthetists to redesign the socket. The aim of this research is to assess the accuracy of prosthetic sockets manufactured by commercial companies. Determination of how and where manufacturing errors occur will contribute to better quality of socket fit for the amputee patient and improve the efficiency of prosthetists who fit the manufactured products to their patients.\n\nComputer manufactured sockets are made for subjects, then their fits assessed by research practitioners.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'people with lower limb amputation that are ambulatory', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* trans-tibial amputees who use a prosthesis and are ambulatory\n\nExclusion Criteria:\n\n* do not have a prosthesis, cannot ambulate'}, 'identificationModule': {'nctId': 'NCT01245504', 'briefTitle': 'Assessment of Socket Shapes Made by Central Fabrication Facilities', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities', 'orgStudyIdInfo': {'id': '31673 E/B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lower-limb amputee', 'description': 'Subjects with at least one lower limb amputated at teh trans-tibial level', 'interventionNames': ['Other: Assessed for socket fit']}], 'interventions': [{'name': 'Assessed for socket fit', 'type': 'OTHER', 'description': 'Subjects are clinically assessed during standing to see how well computer manufactured sockets fit', 'armGroupLabels': ['Lower-limb amputee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington, Bioengineering Department', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joan Sanders', 'investigatorAffiliation': 'University of Washington'}}}}