NCT07154550

Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 0 Weeks – 12 Weeks
• Healthy volunteers: Not accepted

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.

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. * 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

• Club Foot

Interventions

Type	Name	Description
DEVICE	Mastisol	a liquid adhesive used to secure dressings for extended periods of time

Timeline

• Start date: 2026-02-11
• Primary completion: 2032-11-01
• Completion: 2032-11-01
• First posted: 2025-09-04
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study