RecruitingNot ApplicableNCT07154550
Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
Sponsor
University of Wisconsin, Madison
Enrollment
100 participants
Start Date
Feb 11, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 0 WeeksMax Age: 12 Weeks
Inclusion Criteria4
- Patients with bilateral clubfeet
- Starting standard of care treatment with the Ponseti method between 0-12 weeks of age
- For patients born pre-maturely their eligibility age will be based on a corrected gestational age
- Patients for whom at least one parent/guardian is able to converse, read, and write in English
Exclusion Criteria4
- Patients who do not have bilateral clubfoot
- Patients who are starting treatment for clubfoot after 12 weeks of age
- Patients whose parents/guardians are unable to converse, read, and write in English
- Patients whose parents/guardian do not provide or are not able to provide informed consent
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Interventions
DEVICEMastisol
a liquid adhesive used to secure dressings for extended periods of time
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07154550