Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System
- Conditions
- Lower Limb Amputation
- Interventions
- Device: Prosthetic Suction or Pin SocketDevice: Prosthetic LimbLogic Vacuum Socket
- Registration Number
- NCT01839123
- Lead Sponsor
- Ohio Willow Wood
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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
- Impaired contra lateral leg
- Uses vacuum suspension with their current prosthesis
- Diagnosis of renal failure
- Smoker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Non-Vacuum Socket Prosthetic Suction or Pin Socket Prosthetic suction or pin socket Vacuum Socket Prosthetic LimbLogic Vacuum Socket Prosthetic LimbLogic vacuum socket
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 speckle flowmetry tissue perfusion values at 16wks 16 weeks Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks
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
Trial Locations
- Locations (2)
The Ohio State University Davis Heart and Lung Research Institute
🇺🇸Columbus, Ohio, United States
The Ohio Willow Wood Company
🇺🇸Mt. Sterling, Ohio, United States