Pressure UlcerNCT00504855
Cast Sores With Waterproof Vs. Standard Cast Padding
A study testing Casting using Gortex (waterproof) cast padding materials and Casting using cotton/cotton-poly cast padding materials in people with Pressure Ulcer, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
The purpose of this study is to compare waterproof cast padding material to standard cotton/poly-cotton cast padding material to the presence or absence of cast sores of the heel. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Casting using Gortex (waterproof) cast padding materials and Casting using cotton/cotton-poly cast padding materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Mar 2014
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient at Shriners Hospital for Children - Honolulu
- Ages 0-18
- Short leg, long leg, spica or Petrie cast that includes the foot
- Cast applied in the operating room
Who cannot join
- Ponsetti casts (club foot casts with no more surgery than Achilles tenotomy, age < 1 year)
- Splints
- cylinder casts or spicas which don't include the foot
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children - Honolulu
Honolulu, Hawaii, 96826
About this study
Official title: Cast Sores With Waterproof Vs. Standard Cast Padding in a Pediatric Population
The purpose of this study is to compare waterproof cast padding material to standard cotton/poly-cotton cast padding material to the presence or absence of cast sores of the heel.
Read the detailed description
Cast sores result in pain, scarring and sometimes disfigurement. No study has specifically evaluated the efficacy of waterproof cast padding with respect to preventing lower extremity cast sores.
Comparison: Non-blinded randomization to waterproof or cotton/cotton-poly cast padding material in a pediatric population who have lower extremity casts that include the foot and are applied in the operating room. Comparison of cast sore incidence will be made in the two randomized groups.
- Conditions
- Pressure Ulcer
- Being tested
- Casting using Gortex (waterproof) cast padding materials, Casting using cotton/cotton-poly cast padding materials
- Keywords
- Pressure ulcer, Waterproof, Gortex, Cast padding, Pediatric, Heel
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casting using Gortex (waterproof) cast padding materialsOther
Casting using cotton/cotton-poly cast padding materialsOther
| Study group | Role | What they receive |
|---|---|---|
| Gortex (Waterproof) Cast Padding | Active comparator | Randomized application of one of two cast padding materials Receives: Other: Casting using Gortex (waterproof) cast padding materials |
| Cotton/Cotton-Poly Cast Padding | Active comparator | Randomized application of one of two cast padding materials Receives: Other: Casting using cotton/cotton-poly cast padding materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerations
Measured: Time of cast application to final cast removal
Secondary outcomes (1)
Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification.
Measured: Cast application to final cast removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2012
- Study completionMar 2014 (estimated)
Why it stopped: Staffing changes resulted in the expiration of IRB approval (2/15/12), and recruitment halted (n=84). IRB approval is now current for retrospective analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies 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
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan B. Pellett, Shriners Hospitals for Children
- Investigators
- Jonathan B Pellett, MD, Principal investigator, Shriners Hospitals for Children, HonoluluArabella I Leet, MD, Principal investigator, Shriners Hospitals for Children, Honolulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504855
- Sponsor's protocol ID
- SHCH-JPB-1
- Status last verified
- Apr 2013
- First submitted
- 19 Jul 2007
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wagner FW Jr. Treatment of the diabetic foot. Compr Ther. 1984 Apr;10(4):29-38. No abstract available.
PubMed 6723248
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cast Sores With Waterproof Vs. Standard Cast Padding in a Pediatric Population
- ClinicalTrials.gov ID
- NCT00504855
- Acronym / sponsor ID
- SHCH-JPB-1
- Conditions
- Pressure Ulcer
- Keywords
- Pressure ulcer, Waterproof, Gortex, Cast padding, Pediatric, Heel
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staffing changes resulted in the expiration of IRB approval (2/15/12), and recruitment halted (n=84). IRB approval is now current for retrospective analysis.
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2014 (estimated)
- First posted
- 20 Jul 2007 (estimated)
- 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 this study is to compare waterproof cast padding material to standard cotton/poly-cotton cast padding material to the presence or absence of cast sores of the heel.
Detailed description
Cast sores result in pain, scarring and sometimes disfigurement. No study has specifically evaluated the efficacy of waterproof cast padding with respect to preventing lower extremity cast sores.
Comparison: Non-blinded randomization to waterproof or cotton/cotton-poly cast padding material in a pediatric population who have lower extremity casts that include the foot and are applied in the operating room. Comparison of cast sore incidence will be made in the two randomized groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gortex (Waterproof) Cast Padding | Active comparator | Other: Casting using Gortex (waterproof) cast padding materialsRandomized application of one of two cast padding materials |
| Cotton/Cotton-Poly Cast Padding | Active comparator | Other: Casting using cotton/cotton-poly cast padding materialsRandomized application of one of two cast padding materials |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient at Shriners Hospital for Children - Honolulu
- Ages 0-18
- Short leg, long leg, spica or Petrie cast that includes the foot
- Cast applied in the operating room
Key exclusion criteria (3 listed)
- Ponsetti casts (club foot casts with no more surgery than Achilles tenotomy, age < 1 year)
- Splints
- cylinder casts or spicas which don't include the foot
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 |
|---|---|---|
| Casting using Gortex (waterproof) cast padding materials | Other | Gortex (Waterproof) Cast Padding |
| Casting using cotton/cotton-poly cast padding materials | Other | Cotton/Cotton-Poly Cast Padding |
Primary outcome
Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerations
Time frame: Time of cast application to final cast removal
1 secondary outcome
Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification.
Time frame: Cast application to final cast removal
Results and safety
The study was stopped early (reason given: Staffing changes resulted in the expiration of IRB approval (2/15/12), and recruitment halted (n=84). IRB approval is now current for retrospective analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
- Background: PubMed 6723248Wagner FW Jr. Treatment of the diabetic foot. Compr Ther. 1984 Apr;10(4):29-38. No abstract available.
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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.
Jonathan B Pellett, MD principal investigator
Shriners Hospitals for Children, Honolulu
Arabella I Leet, MD principal investigator
Shriners Hospitals for Children, Honolulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casting using Gortex (waterproof) cast padding materials and Casting using cotton/cotton-poly cast padding materials in people with Pressure Ulcer, run by Shriners Hospitals for Children 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Apr 2013. 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 stopped early (reason given: Staffing changes resulted in the expiration of IRB approval (2/15/12), and recruitment halted (n=84). IRB approval is now current for retrospective analysis.). Results are not available in the source record.
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?
Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerations (time frame: Time of cast application to final cast removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00504855, which also lists 1 linked publication.
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 Apr 2013; AzTrials last refreshed its copy on 31 Oct 2026.