Recruiting

E-Socket

Sponsor:

University of Washington

Code:

NCT06432335

Conditions

Trans-Tibial Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

E-Socket Monitoring

Study Details

Brief 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. 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

Study ID

NCT06432335

Start date

Nov 1, 2026

Status verified date

May, 2026

Completion date

Jun 30, 2033

Anticipated

Primary completion date

Jun 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: E-Socket Monitoring

Interventions

E-Socket Monitoring

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.

Primary outcome measure

  • Anterior-Distal Limb Motion [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Tessa Viljamma

206-221-5873tessasv@uw.edu

Locations

Foege Hall - University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Sanders

206-221-5872jsanders@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Nov 4, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by University of Washington on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.