Clinical trial NCT01839123: Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System
Official title: Prosthetic Socket System: Pilot Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Limb Amputation
Keywords: Amputee
Lead sponsor: Ohio Willow Wood
Sponsor class: INDUSTRY
Collaborators: name: Ohio State University
First posted: 2013-04-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
timeFrame: 16 weeks
Secondary outcomes:
measure: Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks
timeFrame: 8 weeks
measure: Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks
timeFrame: 8 weeks
measure: Hyperspectral Imaging StO2% at 16wks
timeFrame: 16 weeks
measure: Laser speckle flowmetry tissue perfusion values at 8wks
timeFrame: 8 weeks
measure: Laser speckle flowmetry tissue perfusion values at 16wks
timeFrame: 16 weeks
measure: Laser Doppler flowmetry tissue perfusion values at 8wks
timeFrame: 8 weeks
measure: Laser Doppler flowmetry tissue perfusion values at 16wks
timeFrame: 16 weeks
Other outcomes:
measure: Skin temperature values at 8wk
timeFrame: 8 weeks
measure: Prosthesis evaluation questionnaire (PEQ)
timeFrame: 16 weeks
Locations:
city: Columbus
country: United States
facility: The Ohio State University Davis Heart and Lung Research Institute
state: Ohio
city: Mt. Sterling
country: United States
facility: The Ohio Willow Wood Company
state: Ohio
Study officials:
affiliation: Ohio State University
name: Gayle Gordillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.