Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
November 11, 2008
Clinicaltrials.gov
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, May 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00117793
Purpose
The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that could be mitigated by the application of negative pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual limb response to a vacuum suspension system and to measure prosthetic performance in comparison to a typical suction suspension system.
The proposed research plan involves two sets of human subject experiments: (1) prospective, randomized cross-over study to quantify performance of a vacuum suspension system as compared to a total surface bearing suction socket in terms of pistoning, maintaining limb volume, step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen tension as a function of vacuum pressure.
Condition Intervention
Amputation
Diabetes
Leg Injuries
Traumatic Amputations
Device: Total Surface Bearing Suction Socket
Device: Vacuum assisted socket system
MedlinePlus related topics: Amputees Diabetes Leg Injuries and Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Efficacy Study
Official Title: Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
Limb volume [ Time Frame: Measurements will be taken after a three week acclimation period for each intervention ] [ Designated as safety issue: No ]
Estimated Enrollment: 40
Study Start Date: August 2005
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Current clinical practice Device: Total Surface Bearing Suction Socket
Current clinical practice
2: Experimental
Novel socket system Device: Vacuum assisted socket system
Novel socket system
Detailed Description:
A proper fitting prosthetic socket provides the amputee with a comfortable system allowing them to pursue many of their desired vocational and recreational goals. Unfortunately, many amputees live with an ill-fitting socket and can experience limb pistoning within the socket, which in turn may result in skin irritation, tissue breakdown, discomfort, and a reduction in activity. One of the key factors affecting fit is intraday residual limb volume changes. For an amputee with dysvascular conditions, the implications of a poor fitting socket are exacerbated by poor circulation, reduced healing potential and the compressive forces exerted by their prosthesis.
Vacuum suspension systems may have the potential to alleviate these conditions for healthy and dysvascular amputees. The purported benefits of vacuum suspension systems include, but are not limited to: improved suspension (reduction in the amount of pistoning), maintenance of limb volume throughout the day, and increased tissue oxygenation to the residual limb.
Our first objective is to characterize performance, as related to socket fit, of a vacuum suspension system using objective and subjective measures. We will do this by conducting a within-subject experiment to measure pistoning in three dimensions while walking, overall and regional changes in limb volume before and after a thirty-minute treadmill walk, mobility (step counts) and the perception of socket fit (questionnaire) as a function of prosthetic prescription (vacuum suspension system vs. total surface bearing suction socket).
Our second objective is to determine the effect of pressures within a prosthetic socket on residual limb transcutaneous oxygen tension (tcpO2) levels. We will conduct laboratory-based, in situ testing to determine how the transcutaneous oxygen tension levels, at six sites on the residual limb, respond to pressures simulating those within a vacuum suspension system and a total surface bearing suction socket.
The proposed research will allow us to understand how suspension systems influence prosthetic socket fit and residual limb tissue health and to formulate a knowledge base on two suspension systems providing prosthetists and clinicians the objective data to make better prescription decisions. In addition, the methods utilized in this study (e.g., a residual limb limb volume scanner and assessing dynamic pistoning) can be used to study current and novel suspension systems, liners, and prosthetic socket designs to provide a standard for comparison.
Eligibility
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
Be over 18 years of age and less than 70 years of age
Have been fit with a prosthesis and have used a prosthesis for at least one year
Wear the prosthesis at least 6 hours per day and be moderately active
Ambulate without upper extremity aids
Able to walk at a steady pace for at least 30 minutes on a treadmill
Have a history of no falls within the previous 6 months
Be cognitively intact so as to understand the research protocols in which they are participating
Exclusion Criteria:
The etiology of amputation was a tumor and there is an active tumor or treatment of tumor
They have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that would interfere with their gait pattern
Their residual limb is ulcerated
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117793
Contacts
Contact: Janice A Pecoraro, RN (206) 764-2962
Contact: Wesley Edmundson (206) 277-2991
Locations
United States, Washington
VA Puget Sound Health Care System, Seattle Recruiting
Seattle, Washington, United States, 98108
Contact: Ricardo Gonzalez 202-254-0196 ricardo.gonzalez@va.gov
Principal Investigator: Glenn K. Klute, PhD
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Glenn K. Klute, PhD VA Puget Sound Health Care System, Seattle
More Information
Click here for more information about this study: Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
Responsible Party: Department of Veterans Affairs ( Klute, Glenn - Principal Investigator )
Study ID Numbers: A3666
First Received: July 1, 2005
Last Updated: May 6, 2008
ClinicalTrials.gov Identifier: NCT00117793
Health Authority: United States: Federal Government
Keywords provided by Department of Veterans Affairs:
Amputee
Artificial limbs
Gait
Walking
Study placed in the following topic categories:
Wounds and Injuries
Diabetes Mellitus
Disorders of Environmental Origin
Leg Injuries
Amputation, Traumatic
Votes:26
Comments: 0