A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 2 months
Healthy Volunteers: f
View:
• 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
Locations
United States
Wisconsin
UW-Health Pediatric Orthopedics Clinics
RECRUITING
Madison
Contact Information
Primary
Ava Barker
barker@ortho.wisc.edu
(608)-263-2356
Time Frame
Start Date: 2026-02-11
Estimated Completion Date: 2032-11
Participants
Target number of participants: 100
Treatments
Experimental: Leg with Mastisol
No_intervention: Control Leg
Related Therapeutic Areas
Sponsors
Leads: University of Wisconsin, Madison