NCT01839123

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 1, 2013

Status Verified

June 1, 2013

Enrollment Period

1.4 years

First QC Date

April 19, 2013

Last Update Submit

June 27, 2013

Conditions

Lower Limb Amputation

Keywords

Amputee

Outcome Measures

Primary Outcomes (1)

  • Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks

    Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks

    16 weeks

Secondary Outcomes (7)

  • Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks

    8 weeks

  • Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks

    8 weeks

  • Hyperspectral Imaging StO2% at 16wks

    16 weeks

  • Laser speckle flowmetry tissue perfusion values at 8wks

    8 weeks

  • Laser speckle flowmetry tissue perfusion values at 16wks

    16 weeks

  • +2 more secondary outcomes

Other Outcomes (2)

  • Skin temperature values at 8wk

    8 weeks

  • Prosthesis evaluation questionnaire (PEQ)

    16 weeks

Study Arms (2)

Non-Vacuum Socket

ACTIVE COMPARATOR

Prosthetic suction or pin socket

Device: Prosthetic Suction or Pin Socket

Vacuum Socket

EXPERIMENTAL

Prosthetic LimbLogic vacuum socket

Device: Prosthetic LimbLogic Vacuum Socket

Interventions

Prosthetic Suction or Pin SocketDEVICE

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.

Also known as: Pin and Lock Suspension, Pin Socket, Suction Suspension, Suction Socket
Non-Vacuum Socket
Prosthetic LimbLogic Vacuum SocketDEVICE

Prosthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump

Vacuum Socket

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Impaired contra lateral leg
  • Uses vacuum suspension with their current prosthesis
  • Diagnosis of renal failure
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ohio State University Davis Heart and Lung Research Institute

Columbus, Ohio, 43210, United States

RECRUITING

The Ohio Willow Wood Company

Mount Sterling, Ohio, 43143, United States

RECRUITING

Related Publications (1)

  • Rink C, Wernke MM, Powell HM, Gynawali S, Schroeder RM, Kim JY, Denune JA, Gordillo GM, Colvin JM, Sen CK. Elevated vacuum suspension preserves residual-limb skin health in people with lower-limb amputation: Randomized clinical trial. J Rehabil Res Dev. 2016;53(6):1121-1132. doi: 10.1682/JRRD.2015.07.0145.

    PMID: 28355039DERIVED

Study Officials

  • Gayle Gordillo, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Schroeder

CONTACT

740-869-3377ryans@owwco.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2013

First Posted

April 24, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

July 1, 2013

Record last verified: 2013-06

Locations

US(2)