Mastisol for Clubfoot

Overseen By Ava Barker

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Unilateral clubfoot, Age over 8 weeks, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Mastisol, a sticky liquid adhesive, can improve casting results for babies born with bilateral clubfoot, a condition where both feet turn inward. The study will examine if Mastisol enhances the casting process and reduces complications up to five years post-treatment. Babies with clubfoot in both feet, starting treatment with the Ponseti method before eight weeks of age, may qualify for this trial. As an unphased trial, it provides an opportunity to contribute to valuable research that could enhance future patient treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Mastisol is safe for use in clubfoot casting?

A previous study showed that Mastisol is safe for use in medical procedures. Mastisol, a liquid glue, often secures bandages or other medical devices on the skin. Most people tolerate it well, and serious side effects are rare. Some might experience mild and temporary skin irritation or redness at the application site.

Although specific safety data for using Mastisol to treat clubfoot is lacking, its general use in medical settings suggests it is unlikely to cause significant harm. Researchers closely monitor participants for any side effects to ensure safety. If the FDA has approved Mastisol for other uses, this also suggests it is safe for this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for clubfoot involve methods like casting, bracing, or surgery to correct the foot's position. But Mastisol offers a different approach. It's an adhesive liquid traditionally used to help medical dressings stick better. Researchers are excited because Mastisol might improve the effectiveness of non-surgical methods by keeping corrective devices in place more securely. This could potentially reduce the need for more invasive procedures, offering a simpler and less intrusive option for managing clubfoot.

What evidence suggests that Mastisol is effective for clubfoot?

Research is exploring whether Mastisol can enhance the effectiveness of the Ponseti method for treating clubfoot. The Ponseti method, a well-known treatment, involves gently moving and casting the foot. This method has a high success rate, with studies showing it works 93.5% of the time over five years. In this trial, one leg will receive treatment with Mastisol, a liquid adhesive that may help keep the casts in place better, potentially reducing complications. While Mastisol itself isn't being tested directly for clubfoot, it is used to enhance the proven effectiveness of the Ponseti method in treating clubfoot. ^{6 7 8 9 10}

Who Is on the Research Team?

Patrick Touhy, MD

Principal Investigator

UW School of Medicine and Public Health

Kenneth Noonan, MD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for individuals with bilateral clubfoot, specifically to see if using Mastisol liquid adhesive can improve their treatment outcomes during casting. The study will follow participants up to 5 years to monitor long-term effects.

Inclusion Criteria

Patients with bilateral clubfeet

Patients for whom at least one parent/guardian is able to converse, read, and write in English

My baby will start Ponseti treatment for clubfoot between 0-8 weeks old.

Exclusion Criteria

Patients who do not have bilateral clubfoot

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bilateral clubfoot casting with or without Mastisol application

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and clubfoot recurrence

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Mastisol

Trial Overview The intervention being tested is the application of Mastisol, a liquid adhesive, in the process of clubfoot casting. The goal is to determine whether it leads to better results and fewer complications over time.

How Is the Trial Designed?

Group I: Leg with Mastisol Experimental Treatment 1 Intervention

Group II: Control Leg Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10913856/

A Retrospective Analysis of Treatment Outcomes After 3 Years ... One of the most popular treatment options is the Ponseti method, which uses clubfoot manipulation and serial casting. The Ponseti method has ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11232790/

Management outcome of congenital talipes equinovarus ... The outcome of clubfoot management using the Ponseti method is effective, fewer casts are needed, the treatment duration is short, and it is ...

3. heraldopenaccess.us heraldopenaccess.us/openaccess/clinical-experiences-and-midterm-results-of-the-treatment-of-clubfoot-with-the-ponseti-method

Clinical Experiences and Midterm Results of the Treatment ... Results: The mean Pirani score for the 92 feet studied was 3.62 ± 0.58 before the treatment. This score dropped significantly to 0.36 ± 0.42 after the course of ...

4. link.springer.com link.springer.com/article/10.1007/s00590-022-03353-5

A 5-years results of the Ponseti method in the treatment ... According to the results from a 5-years data showed that the Ponseti method in the treatment of congenital clubfoot was successful with a success rate of 93.5%.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0929664618300573

Comparison of two methods for idiopathic clubfoot treatment At the latest follow-up, the outcome measures were 24 feet (41.4%) good, 18 feet (31%) fair and 16 (27.6%) poor in the Kite group and 25 feet (83.3%) good, 3 ...

6. withpower.com withpower.com/trial/phase-talipes-9-2025-c752f

Mastisol for Clubfoot · Info for Participants Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and clubfoot recurrence. 5 years. What Are the ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25117413/

Interventions for congenital talipes equinovarus (clubfoot) Data collection and analysis: Two authors independently assessed risk of bias in included trials and extracted the data. We contacted ...

8. htsyndication.com htsyndication.com/health-daily-digest/article/clinical-trial%3A-comparing-outcomes-and-complications-following-mastisol-application-for-clubfoot-casting/92995519

Clinical Trial: Comparing Outcomes and Complications ... Brief Summary: The purpose of this study is to assess if the application of Mastisol, a liquid adhesive, improves outcomes during bilateral ...

9. mayoclinic.org mayoclinic.org/diseases-conditions/clubfoot/symptoms-causes/syc-20350860

Clubfoot - Symptoms and causes Clubfoot describes a condition present at birth in which a baby's foot is pointed in and down. The tissues connecting the muscles to the bone are called ...

10. orthobullets.com orthobullets.com/pediatrics/4062/clubfoot-congenital-talipes-equinovarus

Clubfoot (congenital talipes equinovarus) - Pediatrics Clubfoot, also known as congenital talipes equinovarus, is a common idiopathic deformity of the foot that presents in neonates. Diagnosis is ...