E-Socket, Diagnostic Monitoring

Trans-Tibial Amputation Clinical Trial

Official title:

E-Socket, Diagnostic Monitoring

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432335
• Other study ID #: STUDY00016676
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2025
• Est. completion date: June 30, 2030

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Nick McCarthy
• Phone: 206-616-9148
• Email: nickmcc[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Trans-Tibial Amputation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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