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Effects of Shrinker Use on Healing and Volume

This study has been terminated.
(Terminated due to lack of enrollment)
Information provided by (Responsible Party):
University of Oklahoma Identifier:
First received: December 20, 2007
Last updated: March 22, 2017
Last verified: March 2017
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".

Condition Intervention
Transtibial Amputation
Device: compression shrinker

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Effects of Shrinker Use on Healing and Volume for Transtibial Amputees

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Reduction in Time to Healing [ Time Frame: 1 year ]
    time to healing in each group

Enrollment: 4
Study Start Date: March 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Shrinker
Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.
Device: compression shrinker
Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker
Other Name: Juzo® Compression Therapy Garment
No Intervention: No Shrinker
Patients will receive no shrinker

Detailed Description:
Edema is an inevitable result of amputation surgery. Persistent edema can affect oxygen and nutrient flow into, as well as waste flow out of the residual limb. Shrinkers are a common and effective treatment for edema. However, their influence on healing and long term limb volume has not been studied. This study will pertain to human subjects affected by primary transtibial amputation. Two interventional groups of patients will use shrinkers with different levels of compression as part of their rehabilitation. A third, control group will not use shrinkers. The groups will be studied to determine the effects of shrinker use on healing and long term residual limb volume.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recently undergone primary transtibial amputation
  • Patients between ages of 18 and 100 years of age

Exclusion Criteria:

  • Undergone previous amputations above the Symes level
  Contacts and Locations
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Please refer to this study by its identifier: NCT00693628

United States, Oklahoma
University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Jonathan Day, BSPO University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics
  More Information

Responsible Party: University of Oklahoma Identifier: NCT00693628     History of Changes
Other Study ID Numbers: 13310
13310 ( Other Identifier: University of Oklahoma Health Sciences Center )
Study First Received: December 20, 2007
Results First Received: March 22, 2017
Last Updated: March 22, 2017

Keywords provided by University of Oklahoma:
transtibial amputation
individuals who have undergone transtibial amputation processed this record on May 25, 2017