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

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.

Study Overview

• Status: Recruiting
• Conditions: Transtibial Amputation
• Intervention / Treatment: Procedure: Walk; Device: E-SWEAT Sensor; Procedure: Yuga post

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ming Liu, PhD; Phone Number: 9195158541; Email: mliu10@ncsu.edu
• Study Contact Backup: Name: Amay Bandodkar, PhD; Phone Number: 9195150417; Email: ajbandod@ncsu.edu

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27695
      • Recruiting
      • Engineering Build III
      • Contact: Ming Liu, PhD; Phone Number: 919-515-8541; Email: mliu10@ncsu.edu

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal walking; Participants walk on a treadmill with user preferred speed.	Procedure: Walk; Treadmill walking; Device: E-SWEAT Sensor; Mounting the E_SWEAT sensor to monitor the lactic density, pressure, and temperature inside the socket
Active Comparator: No load excise - Yuga post; Participants conduct a yuga post which involves their efforts but not load on their residual limbs	Device: E-SWEAT Sensor; Mounting the E_SWEAT sensor to monitor the lactic density, pressure, and temperature inside the socket; Procedure: Yuga post; Participants conduct a yuga post which involves their efforts but not load on their residual limbs

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	periprocedural in the first visit

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: North Carolina State University
• Collaborators: University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2029

Study Registration Dates

• First Submitted: September 11, 2025
• First Submitted That Met QC Criteria: October 9, 2025
• First Posted (Estimated): October 14, 2025

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: pressure ulcer; prosthetic socket; sweat biomarker; residual limb health
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Locomotion; Walking
• Other Study ID Numbers: 26923; HT9425-24-1-0579 (Other Grant/Funding Number: Department of Defense, U.S.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be coded with an ID, which randomly generated.

Drug and device information, study documents

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