Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

NCT07154550 | Recruiting FDA Device

• 3 other identifiers: 2025-0724Protocol Version 1/8/2026SMPH/ORTHO&REHAB/ORTHO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Club Foot

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

  up to 12 weeks

Study Arms (2)

Leg with Mastisol

EXPERIMENTAL

Device: Mastisol

Control Leg

NO INTERVENTION

Interventions

Mastisol DEVICE

a liquid adhesive used to secure dressings for extended periods of time

Also known as: Mastisol Liquid Adhesive

Leg with Mastisol

Eligibility Criteria

• Age: 0 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW-Health Pediatric Orthopedics Clinics

Madison, Wisconsin, 53792, United States

RECRUITING

Related Links

• Mastisol Liquid Adhesive

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Patrick Touhy, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

• Kenneth Noonan, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ava Barker

CONTACT

(608)-263-2356; barker@ortho.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a single group of infant participants will have the intervention randomized to either their left or their right leg

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)