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| ID | Type | Description | Link |
|---|---|---|---|
| VA118-12-C-0038 | Other Grant/Funding Number | Veterans Affairs Innovation Initiative |
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| Name | Class |
|---|---|
| Ohio State University | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Vacuum Socket | Active Comparator | Prosthetic suction or pin socket |
|
| Vacuum Socket | Experimental | Prosthetic LimbLogic vacuum socket |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prosthetic Suction or Pin Socket | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin temperature values at 8wk | 8 weeks | |
| Prosthesis evaluation questionnaire (PEQ) | 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Schroeder | Contact | 740-869-3377 | ryans@owwco.com |
| Name | Affiliation | Role |
|---|---|---|
| Gayle Gordillo, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Davis Heart and Lung Research Institute | Recruiting | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28355039 | Derived | Rink C, Wernke MM, Powell HM, Gynawali S, Schroeder RM, Kim JY, Denune JA, Gordillo GM, Colvin JM, Sen CK. Elevated vacuum suspension preserves residual-limb skin health in people with lower-limb amputation: Randomized clinical trial. J Rehabil Res Dev. 2016;53(6):1121-1132. doi: 10.1682/JRRD.2015.07.0145. |
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| Prosthetic LimbLogic Vacuum Socket | Device | Prosthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump |
|
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 |
| The Ohio Willow Wood Company | Recruiting | Mount Sterling | Ohio | 43143 | United States |
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