Study to Determine if Different Prosthetic Sockets Effect How Much Oxygen is in the Tissue of Lower Limb Amputees While They Are Walking

Summary

Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees during gait and (2) to learn which of five different prosthetic limb systems provides greater tissue oxygenation.

Conditions

• Amputation
• Diabetes Complications
• Leg Injuries
• Traumatic Amputation

Interventions

DEVICE

Pe-Lite and sleeve suspension socket

Prosthetic socket worn by the amputee that has a Pe-lite foam liner between the socket and the residual limb. It is suspended from the residual limb using a sleeve at the top of the socket.

DEVICE

Total Surface bearing a socket with a sleeve suspension but without suction

Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a sleeve at the top of the socket.

DEVICE

Total surface bearing suction socket with a pin lock suspension

Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a pin that protrudes from the bottom of the liner into the socket that is then locked in place by the amputee.

DEVICE

Total surface bearing suction socket with a sleeve suspension

Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket using vacuum suction plus a sleeve at the top of the prosthetic socket to enhance the security of the suspension.

DEVICE

Vacuum-assisted socket system (Harmony System, Otto Bock)

Prosthetic socket worn by the amputee where the a vacuum pump, in this case a mechanically-activated pump, creates a vacuum between the socket and the limb. This vacuum suspends the prosthetic limb from the amputee's residual limb.

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• VA Office of Research and Development

  lead FED

Principal Investigators

• Glenn K Klute, PhD · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-01

Primary Completion

2012-10-26

Completion

2012-10-26

Countries

• United States

Study Locations