Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06432335

E-Socket, Diagnostic Monitoring

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Trans-tibial Amputation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-Socket Monitoring

Other

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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nick McCarthy

CONTACT

[email protected]

206-616-9148

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
May 29, 2024
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.