Effects of Shrinker Use on Healing and Volume

This study has been terminated.
(Termated due to lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00693628
First received: December 20, 2007
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Enrollment: 2
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693628

Locations
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
Investigators
Principal Investigator: Jonathan Day, BSPO University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00693628     History of Changes
Other Study ID Numbers: ORTHJD 07, 13310
Study First Received: December 20, 2007
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
volume
healing
shrinker
transtibial amputation
individuals who have undergone transtibial amputation

ClinicalTrials.gov processed this record on September 16, 2014