E-Socket diagnostic prosthesis monitor for people with transtibial amputation
Official title: E-Socket, Diagnostic Monitoring
Run by University of Washington · NCT06432335 · Data updated 2026-11-12
A device-friendly socket-embedded monitor tests whether the E-Socket data can help clinicians diagnose and manage issues for people with below-knee amputations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | November 1, 2026 |
| Main results expected | June 30, 2032 |
| Study ends | June 30, 2033 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT06432335 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older with unilateral or bilateral transtibial amputation, at least 12 months post-amputation, with a residual limb length of 9 cm or more, who regularly use a definitive prosthesis and can walk for at least 5 minutes.
✕Probably not a fit
Individuals with trans-femoral amputation, reduced skin sensation, ongoing skin breakdown, or regular reliance on assistive devices for ambulation may receive limited or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study centers on an integrated E-Socket that collects diagnostic data from the prosthetic socket to support clinical decisions for people with transtibial amputation. The project plans to add metrics identified as needed and then conduct a randomized control trial to test the diagnostic utility of the collected data in routine care. Based on trial findings, the team aims to develop prognostic capabilities to anticipate health issues. Aim 3 focuses on system development, preparing for future studies involving clinicians treating patients. The device is described as diagnostic in a broad sense and not intended to diagnose specific diseases. Human testing for Prognostic aim is not included in this phase.
Why it matters
Potential benefit: If successful, the E-Socket could improve socket fit and early detection of issues, informing better clinical decisions and potentially preventing complications.
How similar studies have gone: Prior work in prosthetic monitoring has shown promise for socket-embedded sensors, but this exact diagnostic-monitoring approach is being developed and tested in this trial setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 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 * 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, Exclusion Criteria: \- Prosthesis Users: Aims 1 and 2 * Reduced skin sensation * Presence of skin breakdown * Regular use of an assistive device * Persons with trans-femoral amputation Aim 1 Only -Vacuum suspension users
Where it's running
-
Foege Hall - University of Washington
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Joan Sanders — University of Washington
- Study coordinator: Tessa Viljamma
- Email: tessasv@uw.edu
- Phone: 206-221-5873
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.