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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trans-Tibial Amputation
• Intervention / Treatment: Other: E-Socket Monitoring

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nick McCarthy; Phone Number: 206-616-9148; Email: nickmcc@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: E-Socket Monitoring	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Joan Sanders, University of Washington

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00016676

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No