E-Socket, Diagnostic Monitoring

University of Washington

Status: Not yet enrolling

Conditions: Trans-Tibial Amputation

Treatments: Other: E-Socket Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06432335

STUDY00016676

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

E-Socket Monitoring

Other group

Treatment:

Other: E-Socket Monitoring