Lower Limb AmputationNCT01839123
Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System
A study testing Prosthetic Suction or Pin Socket and Prosthetic LimbLogic Vacuum Socket in people with Lower Limb Amputation, run by Ohio Willow Wood at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Prosthetic Suction or Pin Socket and Prosthetic LimbLogic Vacuum Socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Impaired contra lateral leg
- Uses vacuum suspension with their current prosthesis
- Diagnosis of renal failure
- Smoker
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
The Ohio State University Davis Heart and Lung Research Institute
Columbus, Ohio, 43210
Lynn Lambert, Lynn.Lambert@osumc.edu
Gayle Gordillo, MD
- Recruiting
The Ohio Willow Wood Company
Mount Sterling, Ohio, 43143
Jim Colvin
Jeff Denune, CPO
About this study
Official title: Prosthetic Socket System: Pilot Assessment
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.
Read the 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
- Being tested
- Prosthetic Suction or Pin Socket, Prosthetic LimbLogic Vacuum Socket
- Keywords
- Amputee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic Suction or Pin SocketDevice
Also called Pin and Lock Suspension, Pin Socket, Suction Suspension, Suction 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 SocketDevice
Prosthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump
| Study group | Role | What they receive |
|---|---|---|
| Non-Vacuum Socket | Active comparator | Prosthetic suction or pin socket Receives: Device: Prosthetic Suction or Pin Socket |
| Vacuum Socket | Experimental | Prosthetic LimbLogic vacuum socket Receives: Device: Prosthetic LimbLogic Vacuum Socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
Measured: 16 weeks
Secondary outcomes (7)
Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks
Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks
Measured: 8 weeks
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks
Change from baseline in Hyperspectral Imaging StO2% at 8wks
Measured: 8 weeks
Hyperspectral Imaging StO2% at 16wks
change from baseline in Hyperspectral Imaging StO2% at 16wks
Measured: 16 weeks
Laser speckle flowmetry tissue perfusion values at 8wks
Change from baseline in Laser speckle flowmetry tissue perfusion values at 8wks
Measured: 8 weeks
Laser speckle flowmetry tissue perfusion values at 16wks
Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks
Measured: 16 weeks
Laser Doppler flowmetry tissue perfusion values at 8wks
Change from baseline in Laser Doppler flowmetry tissue perfusion values at 8wks
Measured: 8 weeks
Laser Doppler flowmetry tissue perfusion values at 16wks
Change from baseline in Laser Doppler flowmetry tissue perfusion values at 16wks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio Willow Wood
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Responsible party
- Sponsor
- Investigators
- Gayle Gordillo, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839123
- Sponsor's protocol ID
- VA-2012-Aim1
- Other IDs
- VA118-12-C-0038
- Status last verified
- Jun 2013
- First submitted
- 19 Apr 2013
- Last updated
- 1 Jul 2013
- Results posted
- No
Publications
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.
PubMed 28355039
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Socket System: Pilot Assessment
- ClinicalTrials.gov ID
- NCT01839123
- Acronym / sponsor ID
- VA-2012-Aim1
- Conditions
- Lower Limb Amputation
- Keywords
- Amputee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ohio Willow WoodIndustry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Study start
- Apr 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Vacuum Socket | Active comparator | Device: Prosthetic Suction or Pin SocketProsthetic suction or pin socket |
| Vacuum Socket | Experimental | Device: Prosthetic LimbLogic Vacuum SocketProsthetic LimbLogic vacuum socket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consenting Adult
- Unilateral lower extremity amputee
- Currently using a liner with prosthesis
- Uses a prosthesis to ambulate
- Ability to read, write and understand English
Key exclusion criteria (4 listed)
- Impaired contra lateral leg
- Uses vacuum suspension with their current prosthesis
- Diagnosis of renal failure
- Smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthetic Suction or Pin SocketAlso: Pin and Lock Suspension, Pin Socket, Suction Suspension, Suction SocketConventional 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 | Non-Vacuum Socket |
| Prosthetic LimbLogic Vacuum SocketProsthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump | Device | Vacuum Socket |
Primary outcome
Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
Time frame: 16 weeks
Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
7 secondary outcomes
Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks
Time frame: 8 weeks
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks
Time frame: 8 weeks
Hyperspectral Imaging StO2% at 16wks
Time frame: 16 weeks
Laser speckle flowmetry tissue perfusion values at 8wks
Time frame: 8 weeks
Laser speckle flowmetry tissue perfusion values at 16wks
Time frame: 16 weeks
Laser Doppler flowmetry tissue perfusion values at 8wks
Time frame: 8 weeks
Laser Doppler flowmetry tissue perfusion values at 16wks
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
- Derived from this study: PubMed 28355039Rink 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gayle Gordillo, MD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic Suction or Pin Socket and Prosthetic LimbLogic Vacuum Socket in people with Lower Limb Amputation, run by Ohio Willow Wood at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan Schroeder (740-869-3377, ryans@owwco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01839123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2013.