## Protocol Section
### Identification Module
**NCT ID:** NCT06432335

**Brief Title:** E-Socket, Diagnostic Monitoring

**Official Title:** E-Socket, Diagnostic Monitoring

#### Organization Study ID Info
**ID:** STUDY00016676
#### Organization
**Class:** OTHER
**Full Name:** University of Washington
### Status Module
#### Completion Date
**Date:** 2030-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2029-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Washington

#### Responsible Party

**Investigator Affiliation:** University of Washington

**Investigator Full Name:** Joan Sanders

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Trans-Tibial Amputation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: E-Socket Monitoring

**Label:** E-Socket Monitoring

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- E-Socket Monitoring

**Description:** 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.

**Name:** E-Socket Monitoring

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Monitor anterior-distal limb motion in the prosthesis to determine if limb motions and activity changes precede changes in limb health.

**Measure:** Anterior-Distal Limb Motion

**Time Frame:** 12 months

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nickmcc@uw.edu

**Name:** Nick McCarthy

**Phone:** 206-616-9148

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University of Washington

**Name:** Joan Sanders

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
