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NCT Number: NCT07154550

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.

Recruiting

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Key information

Age range

0 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW-Health Pediatric Orthopedics Clinics

Madison, Wisconsin, 53792, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mastisol

Device

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

Other names: Mastisol Liquid Adhesive

Primary outcomes

  1. Number of Weeks Need to Obtain Correction

    Time frame: up to 12 weeks

  2. Incidence of recurrent casting or tenotomy

    Time frame: follow up to 5 years from medical records

  3. Incidence of reconstructive surgery

    Time frame: follow up to 5 years from medical records

Secondary outcomes

  1. Number of Casts to Correction

    Time frame: up to 12 weeks

  2. Number of times that each leg has unplanned re-casting in between visits

    Time frame: up to 12 weeks

  3. Tibio-calcaneal angle measured from radiograph at tenotomy time point

    Time frame: up to 12 weeks

  4. Dorsiflexion angle measure from radiograph at tenotomy time point

    Time frame: up to 12 weeks

  5. Incidence of Adverse Events

    Time frame: up to 12 weeks

    sores, redness, swelling, irritation, obvious slippage

  6. Incidence of Severe Adverse Events

    Time frame: up to 12 weeks

    severe dermatitis

  7. Incidence of formation of complex clubfoot

    Time frame: up to 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Ava Barker

CONTACT

[email protected]

(608)-263-2356

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Sep 4, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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