Study 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.
Cast Sores With Waterproof Vs. Standard Cast Padding
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 19, 2007
CompletedFirst Posted
Study publicly available on registry
July 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedApril 8, 2013
April 1, 2013
4.6 years
July 19, 2007
April 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerations
Time of cast application to final cast removal
Secondary Outcomes (1)
Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification.
Cast application to final cast removal
Study Arms (2)
Gortex (Waterproof) Cast Padding
ACTIVE COMPARATORRandomized application of one of two cast padding materials
Cotton/Cotton-Poly Cast Padding
ACTIVE COMPARATORRandomized application of one of two cast padding materials
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shriners Hospitals for Children - Honolulu
Honolulu, Hawaii, 96826, United States
Related Publications (1)
Wagner FW Jr. Treatment of the diabetic foot. Compr Ther. 1984 Apr;10(4):29-38. No abstract available.
PMID: 6723248BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan B Pellett, MD
Shriners Hospitals for Children, Honolulu
- PRINCIPAL INVESTIGATOR
Arabella I Leet, MD
Shriners Hospitals for Children, Honolulu
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
- Staff Orthopaedic Surgeon
Study Record Dates
First Submitted
July 19, 2007
First Posted
July 20, 2007
Study Start
July 1, 2007
Primary Completion
February 1, 2012
Study Completion
March 1, 2014
Last Updated
April 8, 2013
Record last verified: 2013-04