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
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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