Recruiting

Mastisol

Sponsor:

University of Wisconsin, Madison

Code:

NCT07154550

Conditions

Club Foot

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Mastisol

Study Details

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.

Conditions

Club Foot

Study ID

NCT07154550

Start date

Feb 11, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2032

Anticipated

Primary completion date

Nov, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who do not have bilateral clubfoot
  • Patients who are starting treatment for clubfoot after 12 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Leg with Mastisol

no intervention: Control Leg

Interventions

Mastisol

a liquid adhesive used to secure dressings for extended periods of time

Primary outcome measure

  • Number of Weeks Need to Obtain Correction [ Time Frame: up to 12 weeks ]
  • Incidence of recurrent casting or tenotomy [ Time Frame: follow up to 5 years from medical records ]
  • Incidence of reconstructive surgery [ Time Frame: follow up to 5 years from medical records ]

Central Contacts and Locations

Central contacts

Ava Barker

(608)-263-2356barker@ortho.wisc.edu

Locations

UW-Health Pediatric Orthopedics Clinics

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-08-10.