E-Socket, Diagnostic Monitoring

NCT ID: NCT06432335

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2030-06-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

E-Socket Monitoring

Group Type: OTHER

E-Socket Monitoring

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Joan E Sanders

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joan Sanders

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Central Contacts

Nick McCarthy

Role: CONTACT

nickmcc@uw.edu

206-616-9148

Other Identifiers

STUDY00016676

Identifier Type: -

Identifier Source: org_study_id