Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT01221194
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2010-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Therapeutic Stockings to Prevent Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Larry.Lavery@UTSouthwestern.edu', 'phone': '214-645-0544', 'title': 'Lawrence Lavery, DPM, MPH', 'organization': 'UT Southwestern Medical Center at Dallas'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PFC Stockings', 'description': 'The stocking therapy group will be given PFC shear reducing stockings to wear.\n\nPFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.', 'otherNumAtRisk': 195, 'deathsNumAtRisk': 195, 'otherNumAffected': 99, 'seriousNumAtRisk': 195, 'deathsNumAffected': 7, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Standard Therapy', 'description': 'Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.\n\nStandard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.', 'otherNumAtRisk': 186, 'deathsNumAtRisk': 186, 'otherNumAffected': 99, 'seriousNumAtRisk': 186, 'deathsNumAffected': 7, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 186, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 186, 'numAffected': 9}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New foot ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 186, 'numAffected': 82}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mechanical fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Foot related readmission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-foot related hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Developed Foot Ulcer During Study Time Frame', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFC Stockings', 'description': 'The stocking therapy group will be given PFC shear reducing stockings to wear.\n\nPFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.\n\nStandard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 months', 'description': 'An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PFC Stockings', 'description': 'The stocking therapy group will be given PFC shear reducing stockings to wear.\n\nPFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.'}, {'id': 'FG001', 'title': 'Standard Therapy', 'description': 'Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.\n\nStandard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '195'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '195'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PFC Stockings', 'description': 'The stocking therapy group will be given PFC shear reducing stockings to wear.\n\nPFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.'}, {'id': 'BG001', 'title': 'Standard Therapy', 'description': 'Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.\n\nStandard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.06', 'spread': '11.14', 'groupId': 'BG000'}, {'value': '56.08', 'spread': '6.76', 'groupId': 'BG001'}, {'value': '53.72', 'spread': '9.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 381}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2010-10-13', 'resultsFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2010-10-13', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-12', 'studyFirstPostDateStruct': {'date': '2010-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Developed Foot Ulcer During Study Time Frame', 'timeFrame': '30 months', 'description': 'An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['diabetes', 'foot ulcer prevention', 'therapeutic stockings'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': '1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.\n2. To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.', 'detailedDescription': 'We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women 18 years old or older\n* Diagnosis of Diabetes Mellitus\\*\n* History of diabetes related foot ulceration\n\nSpanish-speaking subjects will be eligible to participate.\n\nExclusion Criteria:\n\n* Active Charcot Arthropathy\n* Gangrene, active infection\n* Midfoot or higher level amputation\n* Alcohol or substance abuse within 6 months\n* Unreliable, unwilling or unable to comprehend informed consent'}, 'identificationModule': {'nctId': 'NCT01221194', 'briefTitle': 'Therapeutic Stockings to Prevent Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Therapeutic Stockings to Prevent Foot Ulcers', 'orgStudyIdInfo': {'id': 'STU 082010-090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard therapy', 'description': 'Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.', 'interventionNames': ['Behavioral: Standard therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PFC Stockings', 'description': 'The stocking therapy group will be given PFC shear reducing stockings to wear.', 'interventionNames': ['Device: PFC Stockings']}], 'interventions': [{'name': 'Standard therapy', 'type': 'BEHAVIORAL', 'description': 'Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.', 'armGroupLabels': ['Standard therapy']}, {'name': 'PFC Stockings', 'type': 'DEVICE', 'description': 'A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.', 'armGroupLabels': ['PFC Stockings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Health & Hospital Systems', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76502', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott & White', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Lawrence Lavery, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern Medical Center at Dallas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Larry Lavery', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}