Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT04086927
Status:
WITHDRAWN
Last Update Posted:
2024-09-19
First Post:
2019-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unna Boots for Ankle Fracture Swelling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2019-09-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline swelling using Figure-8 Measurement', 'timeFrame': 'Baseline (Initial encounter)', 'description': 'Physician uses tape measure to measure angles to determine swelling severity of ankle. This measurement is taken by making a figure eight pattern on the foot and ankle. The measurement is taken three times and then averaged to give the final total.'}, {'measure': 'Mean swelling using Figure-8 Measurement', 'timeFrame': '6 weeks follow up visit', 'description': 'Physician uses tape measure to measure angles to determine swelling severity of ankle. This measurement is taken by making a figure eight pattern on the foot and ankle. The measurement is taken three times and then averaged to give the final total.'}, {'measure': 'Mean pain scores on visual analogue scale at initial encounter', 'timeFrame': 'Baseline (initial encounter)', 'description': 'patients report a pain score of 1-10. 1 being the lowest and 10 being the highest'}, {'measure': 'Mean pain scores on visual analogue scale at 6 week follow up visit', 'timeFrame': '6 weeks follow up visit', 'description': 'patients report a pain score of 1-10. 1 being the lowest and 10 being the highest'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Fractures']}, 'descriptionModule': {'briefSummary': "This study will evaluate the difference in soft tissue swelling prior to surgery and wound complications after surgery between unna boot application versus standard splint application. An unna boot is an extra zinc covered wrap around your leg followed by standard splint application (cotton dressing, plaster, then soft dressing). Prior to surgery the participant's swelling will be measured and compared to the standard splint application group. After surgery, the participant will be monitored for wound complications, pain, and range of motion.", 'detailedDescription': 'The purpose of this study is to compare preoperative swelling and frequency of wound complications in ankle fractures through standard splint and an unna boot compressive dressing with a splint. Quantitative and qualitative measurements will be analyzed to compare edema and wound complications. Secondary goals are to evaluate the quantitative differences in ankle range of motion and visual analogue scale (VAS) pain scores. The hypothesis of this proposed study is that there will be less soft tissue swelling and wound complications with the use of an unna boot when compared to the standard splint. The investigators also hypothesize that there will be improved ankle range of motion and visual analogue scale (VAS) pain scores with the use of an unna boot when compared to a standard splint. Participants will be randomized to either the standard splint or an unna boot and quantitative and qualitative measures will be collected. This data could change the practice for preoperative management of soft tissue swelling following ankle fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute ankle fracture\n\nExclusion Criteria:\n\n* low energy ankle fracture\n* open ankle fracture\n* unwillingness to participate\n* allergy to zinc\n* revision surgery'}, 'identificationModule': {'nctId': 'NCT04086927', 'briefTitle': 'Unna Boots for Ankle Fracture Swelling', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Unna Boot: a Technique to Decrease Preoperative Soft Tissue Swelling Following Ankle Fractures', 'orgStudyIdInfo': {'id': '00092143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients will not receive compression dressing'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Patients will receive compression dressing', 'interventionNames': ['Device: Unna Boot']}], 'interventions': [{'name': 'Unna Boot', 'type': 'DEVICE', 'description': 'The unna boot is a zinc coated compression dressing', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christopher E Gross, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic Surgeon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}