Recruiting

Observational StudyEvaluation of Limb Health Associated With a Prosthetic Vacuum Socket System

Sponsor:

Ohio Willow Wood

Code:

NCT01839123

Conditions

Lower Limb Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Prosthetic Suction or Pin Socket

Prosthetic LimbLogic Vacuum Socket

Study Details

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.

Conditions

Lower Limb Amputation

Study ID

NCT01839123

Start date

Apr, 2013

Status verified date

Jun, 2013

Completion date

Sep, 2014

Anticipated

Primary completion date

Sep, 2014

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Non-Vacuum Socket

Prosthetic suction or pin socket

experimental: Vacuum Socket

Prosthetic LimbLogic vacuum socket

Interventions

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.

Prosthetic LimbLogic Vacuum Socket

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

Primary outcome measure

Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Ryan Schroeder

740-869-3377 ryans@owwco.com

Locations

The Ohio State University Davis Heart and Lung Research Institute

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Lynn Lambert

Lynn.Lambert@osumc.edu

Principal Investigator:

Gayle Gordillo, MD

The Ohio Willow Wood Company

Recruiting

Mt. Sterling, Ohio, United States, 43143

More Information

Sponsor

Ohio Willow Wood

Last update posted

Jul 1, 2013

Last verified

Jun, 2013

Keywords

Amputee

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio Willow Wood on 2013-07-01.