Lower Limb Amputation Below Knee (Injury)NCT04305782
NIH Release/Relock Socket
A study testing Release/Relock Socket - In Lab and Release/Relock Socket - Out of Lab in people with Lower Limb Amputation Below Knee (Injury), run by University of Washington at 1 site in United States.
Trial summary
The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- Release/Relock Socket - In Lab and Release/Relock Socket - Out of Lab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 30 Sep 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had trans-tibial amputation at least 18 months prior to enrollment
- Regularly wear a definitive prosthesis for at least 7 hours per week
- Have a residual limb length of at least 9 cm
- K2 or higher MFCL
- Able to walk continuously with a prosthesis for at least 2 minutes at a time
- Sit, stand, and negotiate a step of 5.0 cm
Show all 11Show fewer
- Participants involved remotely will have to meet the following inclusion criteria:
- Have a spare prosthesis
- No cognitive issues
- Good hand dexterity and strength (not frail)
- Capable of communication over a video Zoom conference call.
Who cannot join
- Current presence of skin breakdown
- Unable to satisfy inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington Bioengineering
Seattle, Washington, 98195
Joan E Sanders, PhD, 206-221-5872, jsanders@u.washington.edu
About this study
The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation.
Read the detailed description
Limb fluid volume changes that can occur in the residual limb of a lower-limb amputee can result in changes in socket fit that lead to discomfort, skin injuries, and reduced mobility. It is known that limb fluid volume fluctuations can be reduced for some people by intermittently removing (doffing) the socket throughout the day. It is believed that partially doffing the socket may have a similar benefit, and could be made more convenient thereby promoting easier compliance for prosthetic users.
The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation. The technology enables partial doffing through the release and relock of a socket panel and the prosthetic pin used to hold the limb in place. The expected outcomes are an enhanced understanding of how socket adjustments after activity facilitate limb fluid volume recovery, subsequent fluid retention, and improved socket fit.
- Being tested
- Release/Relock Socket - In Lab, Release/Relock Socket - Out of Lab, Release/Relock Socket & Control
- Keywords
- Prosthetic Socket, Amputee, Pin Lock Prosthetic Socket
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Release/Relock Socket - In LabDevice
The participants will operate the test socket in one of two test conditions: (1) pin re-lock before panel re-lock and (2) panel re-lock before pin re-lock. Participants will test each of the two conditions in a random order, in lab, following a structured protocol. Tests will determine if the order of the re-lock mechanisms influences changes in limb volume.
Release/Relock Socket - Out of LabDevice
The participants will operate the test socket in one of two test conditions: (1) pin re-lock before panel re-lock and (2) panel re-lock before pin re-lock. Participants will test each of the two conditions in a random order, out of lab, with no structured protocol. Tests will determine if the order of the re-lock mechanisms changes participant experience.
Release/Relock Socket & ControlDevice
The participants will operate the test socket in one of two test conditions: (1) release/relock mechanisms enabled and (2) release/relock mechanisms disabled. Participants will test each of the two conditions in a random order, out of lab, with no structured protocol. Tests will determine how the novel release/relock mechanisms compare against traditional socket release methods.
| Study group | Role | What they receive |
|---|---|---|
| Release/Relock Socket - In Lab | Experimental | The test socket will be operated by the participant in lab, following a structured protocol. This arm focuses on the order effects on the re-lock panel and pin mechanisms on limb volume. Receives: Device: Release/Relock Socket - In Lab |
| Release/Relock Socket - Out of Lab | Experimental | The test socket will be operated by the participant out of lab, with no structured protocol. This arm focuses on the effects of the re-lock panel and pin mechanisms on participant comfort. Receives: Device: Release/Relock Socket - Out of Lab |
| Release/Relock Socket & Control | Experimental | The test socket will be operated by the participant out of lab, with no structured protocol. This arm focuses on the comparing participant experience using the novel mechanism versus traditional socket mechanisms. Receives: Device: Release/Relock Socket - In Lab; Device: Release/Relock Socket & Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Limb Volume
Limb volume fluctuations will be measured in real-time as socket release/relock strategies are tested. This will be accomplished using a portable bioimpedance device with thin sticky electrodes that are placed on the residual limb. Specifically, the change in limb volume will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.
Measured: Change from baseline period (no release/relock) to test period (release/relock), commonly each 1 hour long and separated by a seated period of approximately 30 minutes
Prosthesis Evaluation Questionnaire (PEQ)
Participants will be asked to fill out a questionnaire related to their experience using the test socket out of lab in various test configurations. Each question on the PEQ can receive a score form 0 to 100, with higher scores indicating greater satisfaction.
Measured: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.
PROMIS-Fatigue
Participants will be asked to fill out a questionnaire related to their experience using the test socket out of lab in various test configurations. Each PROMIS-Fatigue question asks participants to rank on a scale from 1 to 5 (categorical options), with higher scores indicating greater level of fatigue.
Measured: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.
Socket Comfort Score (SCS)
Participants will be asked to rank their comfort while using the test socket out of lab in various test configurations. The SCS ranges from 0 to 10 (categorical), with higher scores indicating greater level of comfort.
Measured: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Below Knee (Injury)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Joan Sanders, University of Washington
- Investigators
- Joan E Sanders, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305782
- Sponsor's protocol ID
- STUDY00006874
- Other IDs
- 2R01HD060585-08
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2020
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIH Release/Relock Socket
- ClinicalTrials.gov ID
- NCT04305782
- Acronym / sponsor ID
- STUDY00006874
- Keywords
- Prosthetic Socket, Amputee, Pin Lock Prosthetic Socket
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Mar 2020 (actual)
- 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 goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation.
Detailed description
Limb fluid volume changes that can occur in the residual limb of a lower-limb amputee can result in changes in socket fit that lead to discomfort, skin injuries, and reduced mobility. It is known that limb fluid volume fluctuations can be reduced for some people by intermittently removing (doffing) the socket throughout the day. It is believed that partially doffing the socket may have a similar benefit, and could be made more convenient thereby promoting easier compliance for prosthetic users.
The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation. The technology enables partial doffing through the release and relock of a socket panel and the prosthetic pin used to hold the limb in place. The expected outcomes are an enhanced understanding of how socket adjustments after activity facilitate limb fluid volume recovery, subsequent fluid retention, and improved socket fit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Release/Relock Socket - In Lab | Experimental | Device: Release/Relock Socket - In LabThe test socket will be operated by the participant in lab, following a structured protocol. This arm focuses on the order effects on the re-lock panel and pin mechanisms on limb volume. |
| Release/Relock Socket - Out of Lab | Experimental | Device: Release/Relock Socket - Out of LabThe test socket will be operated by the participant out of lab, with no structured protocol. This arm focuses on the effects of the re-lock panel and pin mechanisms on participant comfort. |
| Release/Relock Socket & Control | Experimental | Device: Release/Relock Socket - In Lab, Device: Release/Relock Socket & ControlThe test socket will be operated by the participant out of lab, with no structured protocol. This arm focuses on the comparing participant experience using the novel mechanism versus traditional socket mechanisms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Had trans-tibial amputation at least 18 months prior to enrollment
- Regularly wear a definitive prosthesis for at least 7 hours per week
- Have a residual limb length of at least 9 cm
- K2 or higher MFCL
- Able to walk continuously with a prosthesis for at least 2 minutes at a time
Key exclusion criteria (2 listed)
- Current presence of skin breakdown
- Unable to satisfy inclusion criteria
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 |
|---|---|---|
| Release/Relock Socket - In LabThe participants will operate the test socket in one of two test conditions: (1) pin re-lock before panel re-lock and (2) panel re-lock before pin re-lock. Participants will test each of the two conditions in a random order, in lab, following a structured protocol. Tests will determine if the order of the re-lock mechanisms influences changes in limb volume. | Device | Release/Relock Socket & Control, Release/Relock Socket - In Lab |
| Release/Relock Socket - Out of LabThe participants will operate the test socket in one of two test conditions: (1) pin re-lock before panel re-lock and (2) panel re-lock before pin re-lock. Participants will test each of the two conditions in a random order, out of lab, with no structured protocol. Tests will determine if the order of the re-lock mechanisms changes participant experience. | Device | Release/Relock Socket - Out of Lab |
| Release/Relock Socket & ControlThe participants will operate the test socket in one of two test conditions: (1) release/relock mechanisms enabled and (2) release/relock mechanisms disabled. Participants will test each of the two conditions in a random order, out of lab, with no structured protocol. Tests will determine how the novel release/relock mechanisms compare against traditional socket release methods. | Device | Release/Relock Socket & Control |
Primary outcome
Change in Limb Volume
Time frame: Change from baseline period (no release/relock) to test period (release/relock), commonly each 1 hour long and separated by a seated period of approximately 30 minutes
Limb volume fluctuations will be measured in real-time as socket release/relock strategies are tested. This will be accomplished using a portable bioimpedance device with thin sticky electrodes that are placed on the residual limb. Specifically, the change in limb volume will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.
Prosthesis Evaluation Questionnaire (PEQ)
Time frame: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.
Participants will be asked to fill out a questionnaire related to their experience using the test socket out of lab in various test configurations. Each question on the PEQ can receive a score form 0 to 100, with higher scores indicating greater satisfaction.
PROMIS-Fatigue
Time frame: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.
Participants will be asked to fill out a questionnaire related to their experience using the test socket out of lab in various test configurations. Each PROMIS-Fatigue question asks participants to rank on a scale from 1 to 5 (categorical options), with higher scores indicating greater level of fatigue.
Socket Comfort Score (SCS)
Time frame: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.
Participants will be asked to rank their comfort while using the test socket out of lab in various test configurations. The SCS ranges from 0 to 10 (categorical), with higher scores indicating greater level of comfort.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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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.
Joan E Sanders, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Release/Relock Socket - In Lab and Release/Relock Socket - Out of Lab in people with Lower Limb Amputation Below Knee (Injury), run by University of Washington at 1 site 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 11 inclusion and 2 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Joan E Sanders, PhD (2062215872, jsanders@u.washington.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Limb Volume (time frame: Change from baseline period (no release/relock) to test period (release/relock), commonly each 1 hour long and separated by a seated period of approximately 30 minutes). The study lists 4 primary outcomes in all. 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 29 Apr 2024.