Cast Sores With Waterproof Vs. Standard Cast Padding - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 19, 2007

Last Updated Date

July 19, 2007

Start Date ^†

July 2007

Current Primary Outcome Measures ^†

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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification. [ Time Frame: Cast application to final cast removal ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Cast Sores With Waterproof Vs. Standard Cast Padding

Official Title ^†

Cast Sores With Waterproof Vs. Standard Cast Padding in a Pediatric Population

Brief 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.

Detailed Description

Cast sores result in pain, scarring and sometines 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 Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Pressure Ulcer

Intervention ^†

Other: Gortex cast padding
Other: Cotton/cotton-poly cast padding

Study Arms / Comparison Groups

Active Comparator: Waterproof (Gortex)cast padding
Active Comparator: Cotton/cotton-poly cast padding

Publications *

Wagner FW Jr. Treatment of the diabetic foot. Compr Ther. 1984 Apr;10(4):29-38. No abstract available.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

190

Estimated Completion Date

July 2009

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

1 Year to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Jonathan B Pellett, MD	808-951-3711	jpellett@shrinenet.org
Contact: Ramona R Fillman, MHA, BSPT	808-951-3693	rfillman@shrinenet.org

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00504855

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Shriners Hospitals for Children

Collaborators ^††

Investigators ^†

Principal Investigator:

Jonathan B Pellett, MD

Shriners Hospitals for Children - Honolulu

Information Provided By

Shriners Hospitals for Children

Verification Date

July 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.