NCT01839123

Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System

Prosthetic Socket System: Pilot Assessment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ohio Willow Wood · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lower Limb Amputation

Interventions

Type	Name	Description
DEVICE	Prosthetic 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.
DEVICE	Prosthetic LimbLogic Vacuum Socket	Prosthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-04-24
• Last updated: 2013-07-01

Locations

2 sites across 1 country: United States