Lower Limb Amputation
Conditions
Keywords
Amputee
Brief summary
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
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.
Interventions
DEVICEProsthetic Suction or Pin Socket
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.
DEVICEProsthetic LimbLogic Vacuum Socket
Prosthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump
Sponsors
Ohio State University
Ohio Willow Wood
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks | 16 weeks | Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks | 8 weeks | Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks |
| Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks | 8 weeks | Change from baseline in Hyperspectral Imaging StO2% at 8wks |
| Hyperspectral Imaging StO2% at 16wks | 16 weeks | change from baseline in Hyperspectral Imaging StO2% at 16wks |
| Laser speckle flowmetry tissue perfusion values at 8wks | 8 weeks | Change from baseline in Laser speckle flowmetry tissue perfusion values at 8wks |
| Laser Doppler flowmetry tissue perfusion values at 8wks | 8 weeks | Change from baseline in Laser Doppler flowmetry tissue perfusion values at 8wks |
| Laser Doppler flowmetry tissue perfusion values at 16wks | 16 weeks | Change from baseline in Laser Doppler flowmetry tissue perfusion values at 16wks |
| Laser speckle flowmetry tissue perfusion values at 16wks | 16 weeks | Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks |
Other
| Measure | Time frame |
|---|---|
| Skin temperature values at 8wk | 8 weeks |
| Prosthesis evaluation questionnaire (PEQ) | 16 weeks |
Countries
United States
Contacts
Primary ContactRyan Schroeder
Outcome results
None listed