Status:
NOT_YET_RECRUITING
Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Club Foot
Eligibility:
All Genders
Up to 8 years
Phase:
NA
Brief 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 clubf...
Detailed Description
Study Objectives include: * Determine if application of Mastisol is associated with improved clubfoot outcomes including length of treatment, recurrence of clubfoot, and reconstruction of clubfoot. *...
Eligibility Criteria
Inclusion
- Patients with bilateral clubfeet
- Starting standard of care treatment with the Ponseti method between 0-8 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
- Patients who do not have bilateral clubfoot
- Patients who are starting treatment for clubfoot after 8 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
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2032
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07154550
Start Date
February 1 2026
End Date
November 1 2032
Last Update
January 7 2026
Active Locations (1)
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1
UW-Health Pediatric Orthopedics Clinics
Madison, Wisconsin, United States, 53792