Waterproof Casting Versus Standard Casting for Short Leg Walking Casts

NCT04961957 | Withdrawn DMC FDA Device

• 1 other identifier: 2102248177
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Preference for Same Type of Cast (waterproof short leg walking cast)

  Proportion of patients who, after treatment, express a preference for the same type of cast.

  Upon Cast Removal (3-7 weeks from cast application)

• Preference for Same Type of Cast (non-waterproof short leg walking cast)

  Proportion of patients who, after treatment, express a preference for the same type of cast.

  Upon Cast Removal (3-7 weeks from cast application)

Study Arms (2)

Waterproof padding

ACTIVE COMPARATOR

Waterproof, short leg walking cast for 3-7 weeks

Device: Waterproof padding

Non-waterproof padding

ACTIVE COMPARATOR

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

Device: Non-waterproof padding

Interventions

Waterproof padding DEVICE

Apply waterproof padding to allow for normal bathing and water activities

Waterproof padding

Non-waterproof padding DEVICE

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

Non-waterproof padding

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Ankle Fractures; Ankle Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• David Tager, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This prospective, randomized controlled trial involves the subject being randomized (similar to flipping a coin) by envelope to receive either waterproof padding or non-waterproof padding in their short leg walking cast. The study will take approximately three to seven weeks for the subject to complete (pending date of cast removal).

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 14, 2021
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)