Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System

Study Overview
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Brief Summary
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The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.

Detailed Description
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The prosthetic suspension plays a pivotal role in an amputee's comfort. It can also significantly impact an amputee's limb health. If the prosthesis is not held securely to the amputee's limb, relative movement between the limb and prosthetic interface can cause bruising, skin irritation and skin breakdown. These poor outcomes are uncomfortable and can lead to much more serious health conditions. A positive solution to creating secure and comfortable suspension is the use of a vacuum suspension socket. The vacuum pressure assists in preventing movement in the socket. The clinical benefits associated with vacuum suspension include volume retention, increased proprioception, secure suspension, and frequently reported observations of wound healing. However, the long term effects of vacuum suspension on circulation remain undetermined or undocumented. This study examines a vacuum suspension system on the health of the residual limb (amputated limb). A vacuum socket creates a vacuum between the rigid prosthetic socket and prosthetic liner which is sealed to the socket. Therefore, vacuum is not directly applied to the skin of the residual limb.

Official Title
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Prosthetic Socket System: Pilot Assessment

Conditions
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Lower Limb Amputation

Intervention / Treatment
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* Device: Prosthetic Suction or Pin Socket
* Device: Prosthetic LimbLogic Vacuum Socket


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting Adult Unilateral lower extremity amputee Currently using a liner with prosthesis Uses a prosthesis to ambulate Ability to read, write and understand English Available during regular business hours for appointments Exclusion Criteria: Impaired contra lateral leg Uses vacuum suspension with their current prosthesis Diagnosis of renal failure Smoker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-Vacuum Socket<br>Prosthetic suction or pin socket | Device: Prosthetic Suction or Pin Socket<br>* Conventional prosthetic socket utilizing non-vacuum suspension to secure the residual limb to the prosthesis. Non-vacuum suspension includes pin/lock suspension and suction suspension.<br>* Other names: Suction Socket;|
| Experimental: Vacuum Socket<br>Prosthetic LimbLogic vacuum socket | Device: Prosthetic LimbLogic Vacuum Socket<br>* Prosthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks | Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks | Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks | 8 weeks | 
| Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks | Change from baseline in Hyperspectral Imaging StO2% at 8wks | 8 weeks | 
| Hyperspectral Imaging StO2% at 16wks | change from baseline in Hyperspectral Imaging StO2% at 16wks | 16 weeks | 
| Laser speckle flowmetry tissue perfusion values at 8wks | Change from baseline in Laser speckle flowmetry tissue perfusion values at 8wks | 8 weeks | 
| Laser speckle flowmetry tissue perfusion values at 16wks | Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks | 16 weeks | 
| Laser Doppler flowmetry tissue perfusion values at 8wks | Change from baseline in Laser Doppler flowmetry tissue perfusion values at 8wks | 8 weeks | 
| Laser Doppler flowmetry tissue perfusion values at 16wks | Change from baseline in Laser Doppler flowmetry tissue perfusion values at 16wks | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputee