Trial record 10 of 27 for:    prosthetic limbs | Open Studies

Evaluation of a Novel Transfemoral Prosthetic Socket System

This study is currently recruiting participants.
Verified June 2013 by Ohio Willow Wood
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Ohio Willow Wood
ClinicalTrials.gov Identifier:
NCT01846845
First received: May 1, 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 novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.


Condition Intervention
Lower Limb Amputation
Device: Conventional Prosthetic Transfemoral Socket System
Device: Novel Prosthetic transfemoral socket system

Study Type: Interventional
Study Design: Allocation: Non-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:
  • Laser Doppler flowmetry tissue perfusion values [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month


Secondary Outcome Measures:
  • Laser speckle flowmetry tissue perfusion values [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change from baseline in laser speckle flowmetry tissue perfusion values at 1 month

  • Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change from baseline in hyperspectral imaging StO2% at 1 month

  • Trans-Epidermal Water Loss values [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change from baseline in trans-epidermal water loss values at 1 month

  • Surface electrical capacitance values [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change from baseline in surface electrical capacitance values at 1 month

  • Elasticity (cutometry) values [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change from baseline in elasticity values at 1 month

  • Torsional Ballistometry values [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change from baseline in torsional ballistometry values at 1 month


Other Outcome Measures:
  • Skin temperature values [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change from baseline in skin temperature values at 1 month

  • Prosthesis evaluation questionnaire (PEQ) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Change from baseline in prosthesis evaluation response at 1 month


Estimated Enrollment: 8
Study Start Date: March 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: Conventional TF Socket System
Conventional Prosthetic Transfemoral Socket System
Device: Conventional Prosthetic Transfemoral Socket System
Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket
Other Names:
  • Ischial Containment
  • Pin Transfemoral Socket
  • Suction Transfemoroal Socket
  • Above the knee (AK) socket
Experimental: Novel TF Socket System
Novel Prosthetic Transfemoral Socket System
Device: Novel Prosthetic transfemoral socket system
Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension

Detailed Description:

Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.

  Eligibility

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

Inclusion Criteria:

  • Consenting Adult
  • Unilateral transfemoral amputee
  • Currently suing 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
  • Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.)
  • Diagnosis of renal failure
  • Smoker
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01846845

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    740-869-3377    jimc@owwco.com   
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: NCT01846845     History of Changes
Other Study ID Numbers: VA-2012-Aim3, VA118-12-C-0038
Study First Received: May 1, 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 April 21, 2014