Study Stopped
Terminated due to lack of enrollment
Effects of Shrinker Use on Healing and Volume
1 other identifier
interventional
4
1 country
1
Brief Summary
We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the "transition to stable phase".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 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
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
May 3, 2017
CompletedJune 5, 2017
May 1, 2017
4.8 years
December 20, 2007
March 22, 2017
May 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in Time to Healing
time to healing in each group
1 year
Study Arms (3)
Shrinker
ACTIVE COMPARATORPatients receive 20-30 mmHg compression shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.
No Shrinker
NO INTERVENTIONControl group - participants will not receive an intervention (compression shrinker).
Shrinker 2
ACTIVE COMPARATORPatients receive 30-40 mmHg compression shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.
Interventions
Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker
Eligibility Criteria
You may qualify if:
- Recently undergone primary transtibial amputation
- Patients between ages of 18 and 100 years of age
You may not qualify if:
- Undergone previous amputations above the Symes level
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic
Oklahoma City, Oklahoma, 73104, United States
Limitations and Caveats
Early termination of the study due to poor enrollment numbers, (only 4 subjects were enrolled). No analysis was performed due to insufficient data to assess outcome measures.
Results Point of Contact
- Title
- Jonathan Day
- Organization
- Department of Orthopedic Surgery & Rehabilitation, Orthotics and Prosthetics Division
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Day, BSPO
University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
June 9, 2008
Study Start
March 1, 2007
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
June 5, 2017
Results First Posted
May 3, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share