Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System

NCT01839123 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-07-01

No results posted yet for this study

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

Interventions

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.

DEVICE

Prosthetic LimbLogic Vacuum Socket

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

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER
  • Ohio Willow Wood

    lead INDUSTRY

Principal Investigators

  • Gayle Gordillo, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01839123 on ClinicalTrials.gov