Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System

June 27, 2013 updated by: Ohio Willow Wood

Prosthetic Socket System: Pilot Assessment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Davis Heart and Lung Research Institute
      • Mt. Sterling, Ohio, United States, 43143
        • Recruiting
        • The Ohio Willow Wood Company
        • Contact:
          • Jim Colvin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non-Vacuum Socket
Prosthetic suction or pin socket
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.
Other Names:
  • Pin and Lock Suspension
  • Pin Socket
  • Suction Suspension
  • Suction Socket
Experimental: Vacuum Socket
Prosthetic LimbLogic vacuum socket
Device: Prosthetic LimbLogic Vacuum Socket
Prosthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
Time Frame: 16 weeks
Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks
Time Frame: 8 weeks
Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks
8 weeks
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks
Time Frame: 8 weeks
Change from baseline in Hyperspectral Imaging StO2% at 8wks
8 weeks
Hyperspectral Imaging StO2% at 16wks
Time Frame: 16 weeks
change from baseline in Hyperspectral Imaging StO2% at 16wks
16 weeks
Laser speckle flowmetry tissue perfusion values at 8wks
Time Frame: 8 weeks
Change from baseline in Laser speckle flowmetry tissue perfusion values at 8wks
8 weeks
Laser speckle flowmetry tissue perfusion values at 16wks
Time Frame: 16 weeks
Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks
16 weeks
Laser Doppler flowmetry tissue perfusion values at 8wks
Time Frame: 8 weeks
Change from baseline in Laser Doppler flowmetry tissue perfusion values at 8wks
8 weeks
Laser Doppler flowmetry tissue perfusion values at 16wks
Time Frame: 16 weeks
Change from baseline in Laser Doppler flowmetry tissue perfusion values at 16wks
16 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Skin temperature values at 8wk
Time Frame: 8 weeks
8 weeks
Prosthesis evaluation questionnaire (PEQ)
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio Willow Wood

Collaborators

Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

April 19, 2013

First Submitted That Met QC Criteria

April 19, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

July 1, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VA-2012-Aim1
  • VA118-12-C-0038 (Other Grant/Funding Number: Veterans Affairs Innovation Initiative)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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