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Waterproof Padding vs Non-waterproof Padding for Short Leg Walking Casts

N/A
Waitlist Available
Led By David Tager, MD
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Being placed in a short leg walking cast for one of the diagnoses listed below:
Must not have
Patients with wounds to the foot or ankle prior to cast placement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon cast removal (3-7 weeks from cast application)
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the use of waterproof padding in short leg walking casts to the standard non-waterproof casting in children to see if there is an increase in cast-related complications.

Who is the study for?
This trial is for children who need a short leg walking cast due to conditions like ankle or foot fractures, sprains, toe-walking, tendinitis, or apophysitis. It's not suitable for those with pre-existing wounds on the foot or ankle or cognitive dysfunction that would interfere with the study.
What is being tested?
The study is testing if waterproof padding in short leg walking casts reduces complications compared to standard non-waterproof casting. The goal is to see which type of padding better serves children during their recovery from lower leg injuries.
What are the potential side effects?
Potential side effects may include skin irritation, increased sweating leading to discomfort or rash under the cast with waterproof padding. Standard non-waterproof casts might lead to issues if they get wet and don't dry properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am in a short leg walking cast for a foot or ankle condition.
Select...
I am in a short leg walking cast for a listed condition.
Select...
I have a broken foot.
Select...
I have a broken ankle.
Select...
I walk on my toes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had wounds on my foot or ankle before getting a cast.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon cast removal (3-7 weeks from cast application)
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon cast removal (3-7 weeks from cast application) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Preference for Same Type of Cast (non-waterproof short leg walking cast)
Preference for Same Type of Cast (waterproof short leg walking cast)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Waterproof paddingActive Control1 Intervention
Waterproof, short leg walking cast for 3-7 weeks
Group II: Non-waterproof paddingActive Control1 Intervention
Non-waterproof, short leg walking cast for 3-7 weeks

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor
185 Previous Clinical Trials
64,673 Total Patients Enrolled
David Tager, MDPrincipal InvestigatorWest Virginia University

Media Library

Non-waterproof padding Clinical Trial Eligibility Overview. Trial Name: NCT04961957 — N/A
Ankle Fracture Research Study Groups: Waterproof padding, Non-waterproof padding
Ankle Fracture Clinical Trial 2023: Non-waterproof padding Highlights & Side Effects. Trial Name: NCT04961957 — N/A
Non-waterproof padding 2023 Treatment Timeline for Medical Study. Trial Name: NCT04961957 — N/A
~33 spots leftby Feb 2025
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