Mastisol to help casts stay on for infants with bilateral clubfoot
Official title: A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
Run by University of Wisconsin, Madison · NCT07154550 · Data updated 2026-11-12
This trial tests whether applying Mastisol adhesive before casting helps infants with bilateral clubfoot keep their casts on, shorten treatment, and reduce complications during casting and up to five years afterward.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Weeks to 12 Weeks |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | February 11, 2026 |
| Main results expected | November 2032 |
| Study ends | November 2032 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07154550 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants aged 0–12 weeks with bilateral clubfoot starting Ponseti casting whose parent or guardian can read and speak English and provide consent are ideal candidates.
✕Probably not a fit
Children with unilateral clubfoot, those who begin treatment after 12 weeks of age, or infants whose caregivers cannot provide informed consent in English would not be eligible and are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Infants with bilateral clubfoot beginning Ponseti casting will have Mastisol applied to the skin prior to cast placement and will be followed through their casting course, typically 8–12 weeks. The study will record cast slippage, skin irritation or sores, development of complex clubfoot, length of treatment, recurrence, and any need for reconstructive surgery. Participants will receive standard Ponseti manipulations and casting with or without Mastisol and will be monitored clinically with follow-up extending up to five years. The goal is to determine whether improved cast adherence translates into faster or more durable correction and fewer complications.
Why it matters
Potential benefit: If successful, Mastisol could reduce cast slippage and skin complications, shorten Ponseti casting duration, and lower the chance of clubfoot recurrence or need for reconstruction.
How similar studies have gone: Clinicians commonly use skin adhesives to improve cast adherence and small reports suggest reduced slippage, but robust long-term trial data specifically in clubfoot are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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UW-Health Pediatric Orthopedics Clinics
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Patrick Touhy, MD — UW School of Medicine and Public Health
- Study coordinator: Ava Barker
- Email: barker@ortho.wisc.edu
- Phone: (608)-263-2356
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing standard once-weekly versus accelerated twice-weekly Ponseti casting for club foot
This test will see if doing Ponseti casts twice a week instead of once helps correct club foot in babies younger than six months.
-
French method with or without a foot abduction brace for infant clubfoot
This study will test whether adding a foot abduction brace to the French method helps babies up to 12 months with clubfoot.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.