Effects of Shrinker Use on Healing and Volume

Transtibial Amputation Clinical Trial

Official title:

Effects of Shrinker Use on Healing and Volume for Transtibial Amputees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693628
• Other study ID #: 13310
• Secondary ID: 13310
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: November 30, 2015
• Start date: March 2007
• Est. completion date: January 2012

Study information

• Verified date: November 2015
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Transtibial Amputation

Intervention

Device:
• compression shrinker
Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in time to healing		1 year	No