Prosthetic Socket System: Pilot Assessment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Impaired contra lateral leg
- •Uses vacuum suspension with their current prosthesis
- •Diagnosis of renal failure
结局指标
主要结局
Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
时间窗: 16 weeks
Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
次要结局
- Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks(8 weeks)
- Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks(8 weeks)
- Hyperspectral Imaging StO2% at 16wks(16 weeks)
- Laser speckle flowmetry tissue perfusion values at 8wks(8 weeks)
- Laser speckle flowmetry tissue perfusion values at 16wks(16 weeks)
- Laser Doppler flowmetry tissue perfusion values at 8wks(8 weeks)
- Laser Doppler flowmetry tissue perfusion values at 16wks(16 weeks)
