Waterproof Casting Versus Standard Casting for Short Leg Walking Casts

NCT ID: NCT04961957

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-02-29

Brief Summary

The purpose of the study is to determine whether the use of waterproof padding in short leg walking casts will lead to an increase in cast-related complications, as compared to the standard non-waterproof casting in children.

Detailed Description

This study aims to prospectively examine a group of pediatric patients that receive either a waterproof or non-waterproof short leg cast. From this, we will be able to determine if there are any significant differences between the two groups. If waterproof short leg casts do not cause increased skin breakdown or lead to increases in cast complications and unintended clinic visits, then we can more confidently apply them to pediatric patients, particularly in the summer months when children are more likely to swim.

On application of a waterproof, short leg walking cast, a questionnaire will be distributed to the patient/family to track how many times the cast gets wet. During the application of the cast, materials will be tracked for cost analysis. The subject will return between 3 and 7 weeks for cast removal. On cast removal, the following questionnaires will be completed: cast condition, skin condition, overall patient/family satisfaction, and PROMIS Pediatric Lower Extremity Function - Mobility. Questionnaires will take approximately 5 - 10 minutes to complete. The parent survey regarding how many times the cast got wet will be returned (if applicable). Waterproof and non-waterproof groups will be compared in the basis of cast condition, PROMIS lower extremity survey outcomes, skin condition, overall patient/family satisfaction, number of unintended cast changes or return clinic visits, as well as cost difference.

Outside of the randomization itself, all standard of care procedures or normal practice activities will occur. Each participant will undergo cast application as recommended per standard of care. Study participation does not involve more than minimal risk since everything outside of the randomization is standard of care.

Waterproof and non-waterproof groups will be compared in the basis of cast condition, PROMIS lower extremity survey outcomes, skin condition, overall patient/family satisfaction, number of unintended cast changes or return clinic visits, as well as cost difference. A Chi-Square test will be used to analyze the data.

Conditions

Ankle Fractures; Foot Fracture; Ankle Sprains; Foot Sprain; Toe-walking; Tendonitis of Foot; Apophysitis; Juvenile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Waterproof padding

Waterproof, short leg walking cast for 3-7 weeks

Group Type: ACTIVE_COMPARATOR

Waterproof padding

Intervention Type: DEVICE

Apply waterproof padding to allow for normal bathing and water activities

Non-waterproof padding

Non-waterproof, short leg walking cast for 3-7 weeks

Group Type: ACTIVE_COMPARATOR

Non-waterproof padding

Intervention Type: DEVICE

Apply standard padding that does not allow for normal bathing and water activities

Interventions

Waterproof padding

Apply waterproof padding to allow for normal bathing and water activities

Intervention Type: DEVICE

Non-waterproof padding

Apply standard padding that does not allow for normal bathing and water activities

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Being placed in a short leg walking cast for one of the diagnoses listed below:

• ankle fracture
• foot fracture
• ankle sprain
• foot sprain
• toe-walking
• tendonitis
• apophysitis

Exclusion Criteria

• Patients with wounds to the foot or ankle prior to cast placement
• Patients with cognitive dysfunction

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

David Tager

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Tager, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

2102248177

Identifier Type: -

Identifier Source: org_study_id