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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


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
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