Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
NCT ID: NCT07154550
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-11-30
2032-10-31
Brief Summary
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Detailed Description
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* Determine if application of Mastisol is associated with improved clubfoot outcomes including length of treatment, recurrence of clubfoot, and reconstruction of clubfoot.
* 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.
The 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.
Participants' 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Leg with Mastisol
Mastisol
a liquid adhesive used to secure dressings for extended periods of time
Control Leg
No interventions assigned to this group
Interventions
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Mastisol
a liquid adhesive used to secure dressings for extended periods of time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
0 Weeks
8 Weeks
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Patrick Touhy, MD
Role: PRINCIPAL_INVESTIGATOR
UW School of Medicine and Public Health
Kenneth Noonan, MD
Role: PRINCIPAL_INVESTIGATOR
UW School of Medicine and Public Health
Locations
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UW-Health Pediatric Orthopedics Clinics
Madison, Wisconsin, United States
Countries
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Central Contacts
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Related Links
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Mastisol Liquid Adhesive
Other Identifiers
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Protocol Version 10/7/25
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/ORTHO&REHAB/ORTHO
Identifier Type: OTHER
Identifier Source: secondary_id
2025-0724
Identifier Type: -
Identifier Source: org_study_id