Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
Study NCT ID:
NCT00693628
Status:
TERMINATED
Last Update Posted:
2017-06-05
First Post:
2007-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Shrinker Use on Healing and Volume
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jonathan-day@ouhsc.edu', 'title': 'Jonathan Day', 'organization': 'Department of Orthopedic Surgery & Rehabilitation, Orthotics and Prosthetics Division'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination of the study due to poor enrollment numbers, (only 4 subjects were enrolled). No analysis was performed due to insufficient data to assess outcome measures.'}}, 'adverseEventsModule': {'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed due to early termination.', 'eventGroups': [{'id': 'EG000', 'title': 'Shrinker', 'description': 'Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.\n\ncompression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Shrinker', 'description': 'Patients will receive no shrinker', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction in Time to Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Shrinker', 'description': 'Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.\n\ncompression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker'}, {'id': 'OG001', 'title': 'No Shrinker', 'description': 'Patients will receive no shrinker'}], 'timeFrame': '1 year', 'description': 'time to healing in each group', 'reportingStatus': 'POSTED', 'populationDescription': 'study was closed due to low enrollment. Data were not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Shrinker', 'description': 'Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.\n\ncompression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker'}, {'id': 'FG001', 'title': 'No Shrinker', 'description': 'Patients will receive no shrinker'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'No data is available indicating to which group patients were assigned.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'No data is available indicating to which group patients were assigned .', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Only 4 patients enrolled in study. No data indicating their group assignment', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Only 4 patients enrolled in study. No data indicating their group assignment.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Shrinker', 'description': 'Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.\n\ncompression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker'}, {'id': 'BG001', 'title': 'No Shrinker', 'description': 'Patients will receive no shrinker'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}]}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'Early termination of the study due to poor enrollment numbers, i.e., only 4 subjects were enrolled. No analysis was performed due to insufficient data to assess outcome measures. The number of patients in each group is unknown.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Terminated due to lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2007-12-20', 'resultsFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-22', 'studyFirstPostDateStruct': {'date': '2008-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Time to Healing', 'timeFrame': '1 year', 'description': 'time to healing in each group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['volume', 'healing', 'shrinker', 'transtibial amputation', 'individuals who have undergone transtibial amputation'], 'conditions': ['Transtibial Amputation']}, 'descriptionModule': {'briefSummary': 'We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the "transition to stable phase".', 'detailedDescription': 'Edema is an inevitable result of amputation surgery. Persistent edema can affect oxygen and nutrient flow into, as well as waste flow out of the residual limb. Shrinkers are a common and effective treatment for edema. However, their influence on healing and long term limb volume has not been studied. This study will pertain to human subjects affected by primary transtibial amputation. Two interventional groups of patients will use shrinkers with different levels of compression as part of their rehabilitation. A third, control group will not use shrinkers. The groups will be studied to determine the effects of shrinker use on healing and long term residual limb volume.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recently undergone primary transtibial amputation\n* Patients between ages of 18 and 100 years of age\n\nExclusion Criteria:\n\n* Undergone previous amputations above the Symes level'}, 'identificationModule': {'nctId': 'NCT00693628', 'briefTitle': 'Effects of Shrinker Use on Healing and Volume', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Effects of Shrinker Use on Healing and Volume for Transtibial Amputees', 'orgStudyIdInfo': {'id': '13310'}, 'secondaryIdInfos': [{'id': '13310', 'type': 'OTHER', 'domain': 'University of Oklahoma Health Sciences Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Shrinker', 'description': 'Patients receive 20-30 mmHg compression shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.', 'interventionNames': ['Device: compression shrinker']}, {'type': 'NO_INTERVENTION', 'label': 'No Shrinker', 'description': 'Control group - participants will not receive an intervention (compression shrinker).'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Shrinker 2', 'description': 'Patients receive 30-40 mmHg compression shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.', 'interventionNames': ['Device: compression shrinker']}], 'interventions': [{'name': 'compression shrinker', 'type': 'DEVICE', 'otherNames': ['Juzo® Compression Therapy Garment'], 'description': 'Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker', 'armGroupLabels': ['Shrinker', 'Shrinker 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Jonathan Day, BSPO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}