E-Socket, Diagnostic Monitoring

NCT06432335 | Not Yet Recruiting

• 1 other identifier: STUDY00016676
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (1)

E-Socket Monitoring

OTHER

Other: E-Socket Monitoring

Interventions

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.

E-Socket Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Officials

• Joan Sanders

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nick McCarthy

CONTACT

206-616-9148; nickmcc@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 3, 2024

Record last verified: 2024-05