Expired Study
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Oklahoma City, Oklahoma 73104


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".


Study summary:

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.


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


NCT ID:

NCT00693628


Primary Contact:

Principal Investigator
Jonathan Day, BSPO
University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation,


Backup Contact:

N/A


Location Contact:

Oklahoma City, Oklahoma 73104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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