Ankle FracturesNCT04961957
Waterproof Casting Versus Standard Casting for Short Leg Walking Casts
A study testing Waterproof padding and Non-waterproof padding in people with Ankle Fractures and Foot Fracture, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Ankle Fractures, Foot Fracture, Ankle Sprains
- What is being tested?
- Waterproof padding and Non-waterproof padding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients with wounds to the foot or ankle prior to cast placement
- Patients with cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Waterproof Casting Versus Standard Casting for Short Leg Walking Casts: a Prospective Randomized Controlled Trial
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.
Read the 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
- Being tested
- Waterproof padding, Non-waterproof padding
- Medical subject headings
- Ankle Fractures, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waterproof paddingDevice
Apply waterproof padding to allow for normal bathing and water activities
Non-waterproof paddingDevice
Apply standard padding that does not allow for normal bathing and water activities
| Study group | Role | What they receive |
|---|---|---|
| Waterproof padding | Active comparator | Waterproof, short leg walking cast for 3-7 weeks Receives: Device: Waterproof padding |
| Non-waterproof padding | Active comparator | Non-waterproof, short leg walking cast for 3-7 weeks Receives: Device: Non-waterproof padding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Upon Cast Removal (3-7 weeks from cast application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionFeb 2028 (estimated)
Why it stopped: Casting material has been changed and can no longer proceed with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Tager, West Virginia University
- Investigators
- David Tager, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961957
- Sponsor's protocol ID
- 2102248177
- Status last verified
- Aug 2025
- First submitted
- 7 Jul 2021
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waterproof Casting Versus Standard Casting for Short Leg Walking Casts: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04961957
- Acronym / sponsor ID
- 2102248177
- Conditions
- Ankle Fractures, Foot Fracture, Ankle Sprains, Foot Sprain, Toe-walking, Tendonitis of Foot
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Casting material has been changed and can no longer proceed with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Waterproof padding | Active comparator | Device: Waterproof paddingWaterproof, short leg walking cast for 3-7 weeks |
| Non-waterproof padding | Active comparator | Device: Non-waterproof paddingNon-waterproof, short leg walking cast for 3-7 weeks |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Being placed in a short leg walking cast for one of the diagnoses listed below:
- ankle fracture
- foot fracture
- ankle sprain
- foot sprain
Key exclusion criteria (2 listed)
- Patients with wounds to the foot or ankle prior to cast placement
- Patients with cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Waterproof paddingApply waterproof padding to allow for normal bathing and water activities | Device | Waterproof padding |
| Non-waterproof paddingApply standard padding that does not allow for normal bathing and water activities | Device | Non-waterproof padding |
Primary outcome
Preference for Same Type of Cast (waterproof short leg walking cast)
Time frame: Upon Cast Removal (3-7 weeks from cast application)
Proportion of patients who, after treatment, express a preference for the same type of cast.
Preference for Same Type of Cast (non-waterproof short leg walking cast)
Time frame: Upon Cast Removal (3-7 weeks from cast application)
Proportion of patients who, after treatment, express a preference for the same type of cast.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Tager, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Waterproof padding and Non-waterproof padding in people with Ankle Fractures and Foot Fracture, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference for Same Type of Cast (waterproof short leg walking cast) (time frame: Upon Cast Removal (3-7 weeks from cast application)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.