Epidermal Sensors for Wireless and Enhanced Amputee Skin... | NCT07216183

Studies
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1

NCT07216183

Sponsor

North Carolina State University

Status

Recruiting

Last Update Posted

Oct 14, 2025Actual

Enrollment

16Estimated

Phase

Phase 1

Conditions

Transtibial Amputation

Interventions

Walk
Yuga post
E-SWEAT Sensor

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HT9425-24-1-0579	Other Grant/Funding Number	Department of Defense, U.S.

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2025Actual

Primary Completion Date

Jul 30, 2028Estimated

Completion Date

Jul 30, 2029Estimated

First Submitted Date

Sep 11, 2025

First Submission Date that Met QC Criteria

Oct 9, 2025

First Posted Date

Oct 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2025

Last Update Posted Date

Oct 14, 2025Actual

Name	Class
University of North Carolina, Chapel Hill	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to 1) demonstrate the feasibility of monitoring pressure, temperature, and lactic acid density of sweat inside the prosthetic socket, and 2) verify the relationship between mechanical pressure and Lactic acid density of sweat for lower limb amputees among transtibial amputees. The main questions it aims to answer are:

Is it feasible to reliably monitor pressure, temperature, and lactic acid density inside the prosthetic sockets simultaneously?
Will the lactic acid density increase with higher pressure exposure? The participants are expected to wear the newly developed E-SWEAT system on their residual limb and are exposed to two activities, walk which generate mechanical load on the residual limb, and a yoga post - birddog, which does not generate mechanical loading on the residual limb. The E-SWEAT will measure pressure, temperature, and lactic acid density of sweat during these tasks.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal walking	Experimental	Participants walk on a treadmill with user preferred speed.	Procedure: Walk Device: E-SWEAT Sensor
No load excise - Yuga post	Active Comparator	Participants conduct a yuga post which involves their efforts but not load on their residual limbs	Procedure: Yuga post Device: E-SWEAT Sensor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Walk	Procedure	Treadmill walking	Normal walking
Yuga post

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lactic acid density	amount of lactic acid in sweat	periprocedural in the first visit

Secondary Outcomes

Measure	Description	Time Frame
Socket environment - temperature	temperature at the location where the E-SWEAT is mounted	periprocedural in the first visit
Socket environment - pressure	Pressure measured at the location where the E-SWAET is mounted

Other Outcomes

Measure	Description	Time Frame
Body weight	Participants' body weight	At the beginning of the first visit

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be 18 years or older
Have a unilateral lower limb amputee (below the knee). The tibial length on the residual limb must be greater than half of the length of the tibial on the unaffected side
Have an amputation that occurred over 2 years ago
Have at least 1 year of experience using your prosthetic leg
Have used the current socket for at least 6 months without a significant skin issue or major modification
Be able to comfortably walk 6 mins (with prosthetic legs) without pausing to rest
Be willing to come to North Carolina State University's Centennial Campus to participate in research and be photographed while doing research activities

Exclusion Criteria:

Have a cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
Have any neuropathy observed on the residual limb
Experience numbness, tingling, muscle weakness, and/or pain in your residual limb
Weigh more than 300lbs
Do not want to take photos
Are pregnant or plan to get pregnant
Are allergic to latex, which is often contained in medical tapes.
If you are using medication to control sweat on your residual limb, and your medical provider does not think that it is OK to avoid these medications for 48 hours.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amay Bandodkar, PhD	Contact	9195150417		ajbandod@ncsu.edu
Ming Liu, PhD	Contact	9195158541		mliu10@ncsu.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Engineering Build III	Recruiting	Raleigh	North Carolina	27695	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

All data will be coded with an ID, which randomly generated.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	May 30, 2025	Oct 9, 2025	ICF_000.pdf

ID	Term
D003668	Pressure Ulcer

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D016138	Walking

Ancestor Terms

ID	Term
D008124	Locomotion
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided