Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System

NCT ID: NCT01839123

Last Updated: 2013-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-09-30

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.

Detailed Description

The prosthetic suspension plays a pivotal role in an amputee's comfort. It can also significantly impact an amputee's limb health. If the prosthesis is not held securely to the amputee's limb, relative movement between the limb and prosthetic interface can cause bruising, skin irritation and skin breakdown. These poor outcomes are uncomfortable and can lead to much more serious health conditions. A positive solution to creating secure and comfortable suspension is the use of a vacuum suspension socket. The vacuum pressure assists in preventing movement in the socket. The clinical benefits associated with vacuum suspension include volume retention, increased proprioception, secure suspension, and frequently reported observations of wound healing. However, the long term effects of vacuum suspension on circulation remain undetermined or undocumented.

This study examines a vacuum suspension system on the health of the residual limb (amputated limb). A vacuum socket creates a vacuum between the rigid prosthetic socket and prosthetic liner which is sealed to the socket. Therefore, vacuum is not directly applied to the skin of the residual limb.

Conditions

Lower Limb Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Non-Vacuum Socket

Prosthetic suction or pin socket

Group Type: ACTIVE_COMPARATOR

Prosthetic Suction or Pin Socket

Intervention Type: DEVICE

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.

Vacuum Socket

Prosthetic LimbLogic vacuum socket

Group Type: EXPERIMENTAL

Prosthetic LimbLogic Vacuum Socket

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

Prosthetic LimbLogic Vacuum Socket

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

Intervention Type: DEVICE

Other Intervention Names

Pin and Lock Suspension; Pin Socket; Suction Suspension; Suction Socket

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

Ohio Willow Wood

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gayle Gordillo, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Davis Heart and Lung Research Institute

Columbus, Ohio, United States

Site Status: RECRUITING

The Ohio Willow Wood Company

Mount Sterling, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan Schroeder

Role: CONTACT

ryans@owwco.com

740-869-3377

Facility Contacts

Lynn Lambert

Role: primary

Lynn.Lambert@osumc.edu

Jim Colvin

Role: primary

References

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.

Reference Type: DERIVED

PMID: 28355039 (View on PubMed)

Other Identifiers

VA118-12-C-0038

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VA-2012-Aim1

Identifier Type: -

Identifier Source: org_study_id