NCT00693628

Effects of Shrinker Use on Healing and Volume

Effects of Shrinker Use on Healing and Volume for Transtibial Amputees

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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".

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.

Conditions

• Transtibial Amputation

Interventions

Type	Name	Description
DEVICE	compression shrinker	Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker

Timeline

• Start date: 2007-03-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2008-06-09
• Last updated: 2017-06-05
• Results posted: 2017-05-03

Locations

1 site across 1 country: United States