Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System

Ohio Willow Wood

Status: Unknown

Conditions: Lower Limb Amputation

Treatments: Device: Prosthetic LimbLogic Vacuum Socket; Device: Prosthetic Suction or Pin Socket

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01839123

VA-2012-Aim1

VA118-12-C-0038 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Non-Vacuum Socket

Active Comparator group

Description:

Prosthetic suction or pin socket

Treatment:

Device: Prosthetic Suction or Pin Socket

Vacuum Socket

Experimental group

Description:

Prosthetic LimbLogic vacuum socket

Treatment:

Device: Prosthetic LimbLogic Vacuum Socket