Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

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.

Study Overview

• Status: Recruiting
• Conditions: Club Foot
• Intervention / Treatment: Device: Mastisol

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ava Barker; Phone Number: (608)-263-2356; Email: barker@ortho.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • UW-Health Pediatric Orthopedics Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leg with Mastisol	Device: Mastisol; a liquid adhesive used to secure dressings for extended periods of time; Other Names: Mastisol Liquid Adhesive
No Intervention: Control Leg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Weeks Need to Obtain Correction	up to 12 weeks
Incidence of recurrent casting or tenotomy	follow up to 5 years from medical records
Incidence of reconstructive surgery	follow up to 5 years from medical records

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Casts to Correction		up to 12 weeks
Number of times that each leg has unplanned re-casting in between visits		up to 12 weeks
Tibio-calcaneal angle measured from radiograph at tenotomy time point		up to 12 weeks
Dorsiflexion angle measure from radiograph at tenotomy time point		up to 12 weeks
Incidence of Adverse Events	sores, redness, swelling, irritation, obvious slippage	up to 12 weeks
Incidence of Severe Adverse Events	severe dermatitis	up to 12 weeks
Incidence of formation of complex clubfoot		up to 12 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Patrick Touhy, MD, UW School of Medicine and Public Health; Principal Investigator: Kenneth Noonan, MD, UW School of Medicine and Public Health

Publications and helpful links

Helpful Links

• Mastisol Liquid Adhesive

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032

Study Registration Dates

• First Submitted: August 27, 2025
• First Submitted That Met QC Criteria: August 27, 2025
• First Posted (Actual): September 4, 2025

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Talipes; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Clubfoot
• Other Study ID Numbers: 2025-0724; SMPH/ORTHO&REHAB/ORTHO (Other Identifier: UW Madison); Protocol Version 1/8/2026 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes