RecruitingNot Applicable

Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

United States100 participantsStarted 2026-02-11

Plain-language 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.

Who can participate

Age range

0 Weeks – 12 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Weeks Need to Obtain Correction

Timeframe: up to 12 weeks

Incidence of recurrent casting or tenotomy

Timeframe: follow up to 5 years from medical records

Incidence of reconstructive surgery

Timeframe: follow up to 5 years from medical records

Trial details

NCT IDNCT07154550

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-11

Contact for this trial

Ava Barker

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

View on ClinicalTrials.gov More Club Foot trials

Who can participate

Age range

0 Weeks – 12 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.