Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-01 @ 8:28 PM
Study NCT ID:
NCT04961957
Status:
WITHDRAWN
Last Update Posted:
2025-09-08
First Post:
2021-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Waterproof Casting Versus Standard Casting for Short Leg Walking Casts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}, {'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This prospective, randomized controlled trial involves the subject being randomized (similar to flipping a coin) by envelope to receive either waterproof padding or non-waterproof padding in their short leg walking cast. The study will take approximately three to seven weeks for the subject to complete (pending date of cast removal).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Casting material has been changed and can no longer proceed with the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preference for Same Type of Cast (waterproof short leg walking cast)', 'timeFrame': 'Upon Cast Removal (3-7 weeks from cast application)', 'description': 'Proportion of patients who, after treatment, express a preference for the same type of cast.'}, {'measure': 'Preference for Same Type of Cast (non-waterproof short leg walking cast)', 'timeFrame': 'Upon Cast Removal (3-7 weeks from cast application)', 'description': 'Proportion of patients who, after treatment, express a preference for the same type of cast.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ankle Fractures', 'Foot Fracture', 'Ankle Sprains', 'Foot Sprain', 'Toe-walking', 'Tendonitis of Foot', 'Apophysitis; Juvenile']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether the use of waterproof padding in short leg walking casts will lead to an increase in cast-related complications, as compared to the standard non-waterproof casting in children.', 'detailedDescription': 'This study aims to prospectively examine a group of pediatric patients that receive either a waterproof or non-waterproof short leg cast. From this, we will be able to determine if there are any significant differences between the two groups. If waterproof short leg casts do not cause increased skin breakdown or lead to increases in cast complications and unintended clinic visits, then we can more confidently apply them to pediatric patients, particularly in the summer months when children are more likely to swim.\n\nOn application of a waterproof, short leg walking cast, a questionnaire will be distributed to the patient/family to track how many times the cast gets wet. During the application of the cast, materials will be tracked for cost analysis. The subject will return between 3 and 7 weeks for cast removal. On cast removal, the following questionnaires will be completed: cast condition, skin condition, overall patient/family satisfaction, and PROMIS Pediatric Lower Extremity Function - Mobility. Questionnaires will take approximately 5 - 10 minutes to complete. The parent survey regarding how many times the cast got wet will be returned (if applicable). Waterproof and non-waterproof groups will be compared in the basis of cast condition, PROMIS lower extremity survey outcomes, skin condition, overall patient/family satisfaction, number of unintended cast changes or return clinic visits, as well as cost difference.\n\nOutside of the randomization itself, all standard of care procedures or normal practice activities will occur. Each participant will undergo cast application as recommended per standard of care. Study participation does not involve more than minimal risk since everything outside of the randomization is standard of care.\n\nWaterproof and non-waterproof groups will be compared in the basis of cast condition, PROMIS lower extremity survey outcomes, skin condition, overall patient/family satisfaction, number of unintended cast changes or return clinic visits, as well as cost difference. A Chi-Square test will be used to analyze the data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Being placed in a short leg walking cast for one of the diagnoses listed below:\n\n* ankle fracture\n* foot fracture\n* ankle sprain\n* foot sprain\n* toe-walking\n* tendonitis\n* apophysitis\n\nExclusion Criteria:\n\n* Patients with wounds to the foot or ankle prior to cast placement\n* Patients with cognitive dysfunction'}, 'identificationModule': {'nctId': 'NCT04961957', 'briefTitle': 'Waterproof Casting Versus Standard Casting for Short Leg Walking Casts', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Waterproof Casting Versus Standard Casting for Short Leg Walking Casts: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2102248177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Waterproof padding', 'description': 'Waterproof, short leg walking cast for 3-7 weeks', 'interventionNames': ['Device: Waterproof padding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-waterproof padding', 'description': 'Non-waterproof, short leg walking cast for 3-7 weeks', 'interventionNames': ['Device: Non-waterproof padding']}], 'interventions': [{'name': 'Waterproof padding', 'type': 'DEVICE', 'description': 'Apply waterproof padding to allow for normal bathing and water activities', 'armGroupLabels': ['Waterproof padding']}, {'name': 'Non-waterproof padding', 'type': 'DEVICE', 'description': 'Apply standard padding that does not allow for normal bathing and water activities', 'armGroupLabels': ['Non-waterproof padding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'David Tager, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'David Tager', 'investigatorAffiliation': 'West Virginia University'}}}}