Lower Limb AmputationNCT01846845
Evaluation of a Novel Transfemoral Prosthetic Socket System
A study testing Conventional Prosthetic Transfemoral Socket System and Novel Prosthetic transfemoral socket system 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 novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system. 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?
- Conventional Prosthetic Transfemoral Socket System and Novel Prosthetic transfemoral socket system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 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 transfemoral amputee
- Currently suing 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
- Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.)
- 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, 740-869-3377, jimc@owwco.com
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 novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.
Read the detailed description
Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.
- Conditions
- Lower Limb Amputation
- Being tested
- Conventional Prosthetic Transfemoral Socket System, Novel Prosthetic transfemoral socket system
- Keywords
- Amputee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Prosthetic Transfemoral Socket SystemDevice
Also called Ischial Containment, Pin Transfemoral Socket, Suction Transfemoroal Socket, Above the knee (AK) socket
Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket
Novel Prosthetic transfemoral socket systemDevice
Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension
| Study group | Role | What they receive |
|---|---|---|
| Conventional TF Socket System | Active comparator | Conventional Prosthetic Transfemoral Socket System Receives: Device: Conventional Prosthetic Transfemoral Socket System |
| Novel TF Socket System | Experimental | Novel Prosthetic Transfemoral Socket System Receives: Device: Novel Prosthetic transfemoral socket system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laser Doppler flowmetry tissue perfusion values
Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month
Measured: 1 month
Secondary outcomes (6)
Laser speckle flowmetry tissue perfusion values
Change from baseline in laser speckle flowmetry tissue perfusion values at 1 month
Measured: 1 month
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%)
Change from baseline in hyperspectral imaging StO2% at 1 month
Measured: 1 month
Trans-Epidermal Water Loss values
Change from baseline in trans-epidermal water loss values at 1 month
Measured: 1 month
Surface electrical capacitance values
Change from baseline in surface electrical capacitance values at 1 month
Measured: 1 month
Elasticity (cutometry) values
Change from baseline in elasticity values at 1 month
Measured: 1 month
Torsional Ballistometry values
Change from baseline in torsional ballistometry values at 1 month
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startMar 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.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT01846845
- Sponsor's protocol ID
- VA-2012-Aim3
- Other IDs
- VA118-12-C-0038
- Status last verified
- Jun 2013
- First submitted
- 1 May 2013
- Last updated
- 1 Jul 2013
- Results posted
- No
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
- NCT01846845
- Acronym / sponsor ID
- VA-2012-Aim3
- Conditions
- Lower Limb Amputation
- Keywords
- Amputee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Ohio Willow WoodIndustry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 3 May 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 novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.
Detailed description
Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional TF Socket System | Active comparator | Device: Conventional Prosthetic Transfemoral Socket SystemConventional Prosthetic Transfemoral Socket System |
| Novel TF Socket System | Experimental | Device: Novel Prosthetic transfemoral socket systemNovel Prosthetic Transfemoral Socket System |
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 transfemoral amputee
- Currently suing 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
- Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.)
- 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 |
|---|---|---|
| Conventional Prosthetic Transfemoral Socket SystemAlso: Ischial Containment, Pin Transfemoral Socket, Suction Transfemoroal Socket, Above the knee (AK) socketConventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket | Device | Conventional TF Socket System |
| Novel Prosthetic transfemoral socket systemProsthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension | Device | Novel TF Socket System |
Primary outcome
Laser Doppler flowmetry tissue perfusion values
Time frame: 1 month
Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month
6 secondary outcomes
Laser speckle flowmetry tissue perfusion values
Time frame: 1 month
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%)
Time frame: 1 month
Trans-Epidermal Water Loss values
Time frame: 1 month
Surface electrical capacitance values
Time frame: 1 month
Elasticity (cutometry) values
Time frame: 1 month
Torsional Ballistometry values
Time frame: 1 month
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.
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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 Conventional Prosthetic Transfemoral Socket System and Novel Prosthetic transfemoral socket system 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?
Laser Doppler flowmetry tissue perfusion values (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.