Club FootNCT07154550
Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
A study testing Mastisol in people with Club Foot, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 12 weeks
- Conditions the study is for
- Club Foot
- What is being tested?
- Mastisol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2026to Nov 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW-Health Pediatric Orthopedics Clinics
Madison, Wisconsin, 53792
About this study
Official title: A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
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.
Read the 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.
- Conditions
- Club Foot
- Being tested
- Mastisol
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MastisolDevice
Also called Mastisol Liquid Adhesive
a liquid adhesive used to secure dressings for extended periods of time
| Study group | Role | What they receive |
|---|---|---|
| Leg with Mastisol | Experimental | Not described Receives: Device: Mastisol |
| Control Leg | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Weeks Need to Obtain Correction
Measured: up to 12 weeks
Incidence of recurrent casting or tenotomy
Measured: follow up to 5 years from medical records
Incidence of reconstructive surgery
Measured: follow up to 5 years from medical records
Secondary outcomes (7)
Number of Casts to Correction
Measured: up to 12 weeks
Number of times that each leg has unplanned re-casting in between visits
Measured: up to 12 weeks
Tibio-calcaneal angle measured from radiograph at tenotomy time point
Measured: up to 12 weeks
Dorsiflexion angle measure from radiograph at tenotomy time point
Measured: up to 12 weeks
Incidence of Adverse Events
sores, redness, swelling, irritation, obvious slippage
Measured: up to 12 weeks
Incidence of Severe Adverse Events
severe dermatitis
Measured: up to 12 weeks
Incidence of formation of complex clubfoot
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start11 Feb 2026
- Primary completionNov 2032 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Club FootStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a single group of infant participants will have the intervention randomized to either their left or their right leg
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Touhy, MD, Principal investigator, UW School of Medicine and Public HealthKenneth Noonan, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154550
- Sponsor's protocol ID
- 2025-0724
- Other IDs
- Protocol Version 5/5/2026, SMPH/ORTHO&REHAB/ORTHO
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting
- ClinicalTrials.gov ID
- NCT07154550
- Acronym / sponsor ID
- 2025-0724
- Conditions
- Club Foot
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- Nov 2032 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a single group of infant participants will have the intervention randomized to either their left or their right leg
| Arm | Type | Receives |
|---|---|---|
| Leg with Mastisol | Experimental | Device: Mastisol |
| Control Leg | No intervention | – |
Who may qualify
- Ages
- 0 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with bilateral clubfeet
- Starting standard of care treatment with the Ponseti method between 0-12 weeks of age
- Patients for whom at least one parent/guardian is able to converse, read, and write in English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MastisolAlso: Mastisol Liquid Adhesivea liquid adhesive used to secure dressings for extended periods of time | Device | Leg with Mastisol |
Primary outcome
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
7 secondary outcomes
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
Time frame: up to 12 weeks
Incidence of Severe Adverse Events
Time frame: up to 12 weeks
Incidence of formation of complex clubfoot
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Mastisol Liquid AdhesiveLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Touhy, MD principal investigator
UW School of Medicine and Public Health
Kenneth Noonan, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mastisol in people with Club Foot, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ava Barker ((608)-263-2356, barker@ortho.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Weeks Need to Obtain Correction (time frame: up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.