An interventional study of Mastisol in Club Foot, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 0 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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.
Study Objectives include:
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.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's planned enrollment of 100 is above the median of 38 across 40 interventional studies indexed under Clubfoot.
Browse Clubfoot studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Starting standard of care treatment with the Ponseti method between 0-12 weeks of age
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Mastisol
a liquid adhesive used to secure dressings for extended periods of time
Also known as: Mastisol Liquid Adhesive
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
Number of Casts to Correction
Time frame: up to 12 weeks
Number of times that each leg has unplanned re-casting in between visits
Time frame: up to 12 weeks
Tibio-calcaneal angle measured from radiograph at tenotomy time point
Time frame: up to 12 weeks
Dorsiflexion angle measure from radiograph at tenotomy time point
Time frame: up to 12 weeks
Incidence of Adverse Events
sores, redness, swelling, irritation, obvious slippage
Time frame: up to 12 weeks
Incidence of Severe Adverse Events
severe dermatitis
Time frame: up to 12 weeks
Incidence of formation of complex clubfoot
Time frame: up to 12 weeks
Plan to share: No
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