Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Ohio Willow Wood
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Ohio Willow Wood
ClinicalTrials.gov Identifier:
NCT01839123
First received: April 19, 2013
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Lower Limb Amputation
Device: Prosthetic Suction or Pin Socket
Device: Prosthetic LimbLogic Vacuum Socket

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prosthetic Socket System: Pilot Assessment

Further study details as provided by Ohio Willow Wood:

Primary Outcome Measures:
  • Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks


Secondary Outcome Measures:
  • Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks

  • Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Hyperspectral Imaging StO2% at 8wks

  • Hyperspectral Imaging StO2% at 16wks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    change from baseline in Hyperspectral Imaging StO2% at 16wks

  • Laser speckle flowmetry tissue perfusion values at 8wks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Laser speckle flowmetry tissue perfusion values at 8wks

  • Laser speckle flowmetry tissue perfusion values at 16wks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks

  • Laser Doppler flowmetry tissue perfusion values at 8wks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Laser Doppler flowmetry tissue perfusion values at 8wks

  • Laser Doppler flowmetry tissue perfusion values at 16wks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Laser Doppler flowmetry tissue perfusion values at 16wks


Other Outcome Measures:
  • Skin temperature values at 8wk [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Prosthesis evaluation questionnaire (PEQ) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839123

Contacts
Contact: Ryan Schroeder 740-869-3377 ryans@owwco.com

Locations
United States, Ohio
The Ohio State University Davis Heart and Lung Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Lynn Lambert       Lynn.Lambert@osumc.edu   
Principal Investigator: Gayle Gordillo, MD         
Sub-Investigator: Sashwati Roy, PhD         
Sub-Investigator: Chandan Sen, PhD         
Sub-Investigator: Heather Powell, PhD         
Sub-Investigator: W. Jerry Mysiw, MD         
Sub-Investigator: Cameron Rink, PhD         
The Ohio Willow Wood Company Recruiting
Mt. Sterling, Ohio, United States, 43143
Contact: Jim Colvin         
Sub-Investigator: Jeff Denune, CPO         
Sub-Investigator: James Colvin, MS         
Sponsors and Collaborators
Ohio Willow Wood
Ohio State University
Investigators
Principal Investigator: Gayle Gordillo, MD Ohio State University
  More Information

No publications provided

Responsible Party: Ohio Willow Wood
ClinicalTrials.gov Identifier: NCT01839123     History of Changes
Other Study ID Numbers: VA-2012-Aim1, VA118-12-C-0038
Study First Received: April 19, 2013
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio Willow Wood:
Amputee

ClinicalTrials.gov processed this record on October 19, 2014