Trans-Tibial AmputationNCT06432335
E-Socket, Diagnostic Monitoring
A study testing E-Socket Monitoring in people with Trans-Tibial Amputation, run by University of Washington.
Trial summary
The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trans-Tibial Amputation
- What is being tested?
- E-Socket Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- -
- Prosthesis Users:
- Aims 1 and 2
- Over 18 years of age
- Unilateral or bilateral trans-tibial amputation at least 12 months prior
- Have a limb of length 9 cm or greater
Show all 12Show fewer
- Are capable of at least 5 minutes of continuous walking
- Regularly use a definitive prosthesis
- Do not regularly use assistive devices (e.g., cane, walker) for ambulation
- Do not have open wounds on their residual limb at the time of enrollment
- Aim 2
- -Regularly visit their prosthetist at least twice a year,
Who cannot join
- -
- Prosthesis Users:
- Aims 1 and 2
- Reduced skin sensation
- Presence of skin breakdown
- Regular use of an assistive device
Show all 9Show fewer
- Persons with trans-femoral amputation
- Aim 1 Only
- -Vacuum suspension users
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3).
Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants' own clinicians.
Note: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions.
- Conditions
- Trans-Tibial Amputation
- Being tested
- E-Socket Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Socket MonitoringOther
Limb-socket motion data is collected during participant take-home use. Bimonthly telephone interviews are conducted to assess participant residual limb health status. Analysis is conducted to determine if limb motions and activity changes precede limb health changes.
| Study group | Role | What they receive |
|---|---|---|
| E-Socket Monitoring | Other | Not described Receives: Other: E-Socket Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior-Distal Limb Motion
Monitor anterior-distal limb motion in the prosthesis to determine if limb motions and activity changes precede changes in limb health. Interviews with the participants and questionnaires will be used to assess the outcome measure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trans-Tibial AmputationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan E Sanders, University of Washington
- Investigators
- Joan Sanders, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432335
- Sponsor's protocol ID
- STUDY00016676
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-Socket, Diagnostic Monitoring
- ClinicalTrials.gov ID
- NCT06432335
- Acronym / sponsor ID
- STUDY00016676
- Conditions
- Trans-Tibial Amputation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 29 May 2024 (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 long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3).
Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants' own clinicians.
Note: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-Socket Monitoring | Other | Other: E-Socket Monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -
- Aims 1 and 2
- Over 18 years of age
- Unilateral or bilateral trans-tibial amputation at least 12 months prior
- Have a limb of length 9 cm or greater
Key exclusion criteria (9 listed)
- -
- Aims 1 and 2
- Reduced skin sensation
- Presence of skin breakdown
- Regular use of an assistive device
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 |
|---|---|---|
| E-Socket MonitoringLimb-socket motion data is collected during participant take-home use. Bimonthly telephone interviews are conducted to assess participant residual limb health status. Analysis is conducted to determine if limb motions and activity changes precede limb health changes. | Other | E-Socket Monitoring |
Primary outcome
Anterior-Distal Limb Motion
Time frame: 12 months
Monitor anterior-distal limb motion in the prosthesis to determine if limb motions and activity changes precede changes in limb health. Interviews with the participants and questionnaires will be used to assess the outcome measure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
Related trials for Trans-Tibial Amputation
Active, not recruitingObservational study
Kinematics of Ewing Amputees
Lower Extremity Amputation, Trans-Tibial Amputation
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.
Joan Sanders principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing E-Socket Monitoring in people with Trans-Tibial Amputation, run by University of Washington.
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 12 inclusion and 9 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: opening soon, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nick McCarthy (206-616-9148, nickmcc@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior-Distal Limb Motion (time frame: 12 months). 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 3 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.