Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-04-11 @ 11:52 AM
Study NCT ID:
NCT07154550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003025', 'term': 'Clubfoot'}], 'ancestors': [{'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a single group of infant participants will have the intervention randomized to either their left or their right leg'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Weeks Need to Obtain Correction', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Incidence of recurrent casting or tenotomy', 'timeFrame': 'follow up to 5 years from medical records'}, {'measure': 'Incidence of reconstructive surgery', 'timeFrame': 'follow up to 5 years from medical records'}], 'secondaryOutcomes': [{'measure': 'Number of Casts to Correction', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Number of times that each leg has unplanned re-casting in between visits', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Tibio-calcaneal angle measured from radiograph at tenotomy time point', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Dorsiflexion angle measure from radiograph at tenotomy time point', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'up to 12 weeks', 'description': 'sores, redness, swelling, irritation, obvious slippage'}, {'measure': 'Incidence of Severe Adverse Events', 'timeFrame': 'up to 12 weeks', 'description': 'severe dermatitis'}, {'measure': 'Incidence of formation of complex clubfoot', 'timeFrame': 'up to 12 weeks'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Club Foot']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://eloquesthealthcare.com/mastisol/', 'label': 'Mastisol Liquid Adhesive'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if the application of Mastisol, a liquid adhesive, improves outcomes during bilateral clubfoot casting and reduces complications and development of complex clubfoot for the duration of their casting and up to 5 years follow-up.', 'detailedDescription': "Study Objectives include:\n\n* Determine if application of Mastisol is associated with improved clubfoot outcomes including length of treatment, recurrence of clubfoot, and reconstruction of clubfoot.\n* Assess if the application of Mastisol prior to cast placement is associated with reduced cast slippage and other complications such as severe skin irritation, sores, and development of complex clubfoot.\n\nThe investigators hypothesize that Mastisol application will be associated with improved outcomes by helping to maintain a well-fitting cast, which can be key to reducing complications, optimizing correction (i.e. minimizing treatment time). Proper correction can ultimately be associated with decreased incidence of clubfoot recurrence and need for reconstruction.\n\nParticipants' participation will last roughly 8-12 weeks but may be shorter or longer depending on their response to manipulation and casting. This is a standard expectation with the Ponseti method of clubfoot casting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '0 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with bilateral clubfeet\n* Starting standard of care treatment with the Ponseti method between 0-8 weeks of age\n\n * For patients born pre-maturely their eligibility age will be based on a corrected gestational age\n* Patients for whom at least one parent/guardian is able to converse, read, and write in English\n\nExclusion Criteria:\n\n* Patients who do not have bilateral clubfoot\n* Patients who are starting treatment for clubfoot after 8 weeks of age\n* Patients whose parents/guardians are unable to converse, read, and write in English\n* Patients whose parents/guardian do not provide or are not able to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07154550', 'briefTitle': 'Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting', 'orgStudyIdInfo': {'id': '2025-0724'}, 'secondaryIdInfos': [{'id': 'Protocol Version 10/7/25', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/ORTHO&REHAB/ORTHO', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leg with Mastisol', 'interventionNames': ['Device: Mastisol']}, {'type': 'NO_INTERVENTION', 'label': 'Control Leg'}], 'interventions': [{'name': 'Mastisol', 'type': 'DEVICE', 'otherNames': ['Mastisol Liquid Adhesive'], 'description': 'a liquid adhesive used to secure dressings for extended periods of time', 'armGroupLabels': ['Leg with Mastisol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW-Health Pediatric Orthopedics Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Ava Barker', 'role': 'CONTACT', 'email': 'barker@ortho.wisc.edu', 'phone': '(608)-263-2356'}], 'overallOfficials': [{'name': 'Patrick Touhy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW School of Medicine and Public Health'}, {'name': 'Kenneth Noonan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW School of Medicine and Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}