Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-29 @ 11:02 AM
Study NCT ID:
NCT07154550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: