Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System

Lower Limb Amputation Clinical Trial

Official title:

Prosthetic Socket System: Pilot Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01839123
• Other study ID #: VA-2012-Aim1
• Secondary ID: VA118-12-C-0038
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2013
• Last updated: June 27, 2013
• Start date: April 2013
• Est. completion date: September 2014

Study information

• Verified date: June 2013
• Source: Ohio Willow Wood
• Contact: Ryan Schroeder
• Phone: 740-869-3377
• Email: ryans[@]owwco.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lower Limb Amputation

Intervention

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.
• Prosthetic LimbLogic Vacuum Socket
Prosthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump

Locations

Country	Name	City	State
United States	The Ohio State University Davis Heart and Lung Research Institute	Columbus	Ohio
United States	The Ohio Willow Wood Company	Mt. Sterling	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio Willow Wood	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin temperature values at 8wk		8 weeks	No
Other	Prosthesis evaluation questionnaire (PEQ)		16 weeks	No
Primary	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	No
Secondary	Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks	Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks	8 weeks	No
Secondary	Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks	Change from baseline in Hyperspectral Imaging StO2% at 8wks	8 weeks	No
Secondary	Hyperspectral Imaging StO2% at 16wks	change from baseline in Hyperspectral Imaging StO2% at 16wks	16 weeks	No
Secondary	Laser speckle flowmetry tissue perfusion values at 8wks	Change from baseline in Laser speckle flowmetry tissue perfusion values at 8wks	8 weeks	No
Secondary	Laser speckle flowmetry tissue perfusion values at 16wks	Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks	16 weeks	No
Secondary	Laser Doppler flowmetry tissue perfusion values at 8wks	Change from baseline in Laser Doppler flowmetry tissue perfusion values at 8wks	8 weeks	No
Secondary	Laser Doppler flowmetry tissue perfusion values at 16wks	Change from baseline in Laser Doppler flowmetry tissue perfusion values at 16wks	16 weeks	No