Effects of Shrinker Use on Healing and Volume

Not Applicable

Terminated

• Conditions: Transtibial Amputation
• Interventions: Device: compression shrinker

• Registration Number: NCT00693628
• Lead Sponsor: University of Oklahoma

Brief 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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-09
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2017-03-22
• Results First Submitted QC: 2017-03-22
• Status Verified: 2017-05
• Results First Posted: 2017-05-03
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shrinker 2	compression shrinker	Patients receive 30-40 mmHg compression shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.
Shrinker	compression shrinker	Patients receive 20-30 mmHg compression shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.

Primary Outcome Measures

Name	Time	Method
Reduction in Time to Healing	1 year	time to healing in each group

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic; 🇺🇸 Oklahoma City, Oklahoma, United States