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

NCT07216183 | Recruiting Phase 1 FDA Device

• 2 other identifiers: 26923HT9425-24-1-0579
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Transtibial Amputation

Keywords

sweat biomarker; prosthetic socket; pressure ulcer; residual limb health

Outcome Measures

Primary Outcomes (1)

• Lactic acid density

  amount of lactic acid in sweat

  periprocedural in the first visit

Secondary Outcomes (2)

• Socket environment - temperature

  periprocedural in the first visit

• Socket environment - pressure

  periprocedural in the first visit

Other Outcomes (1)

• Body weight

  At the beginning of the first visit

Study Arms (2)

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

Walk PROCEDURE

Treadmill walking

Normal walking

Yuga post PROCEDURE

Participants conduct a yuga post which involves their efforts but not load on their residual limbs

No load excise - Yuga post

E-SWEAT Sensor DEVICE

Mounting the E\_SWEAT sensor to monitor the lactic density, pressure, and temperature inside the socket

No load excise - Yuga post; Normal walking

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Carolina State University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Engineering Build III

Raleigh, North Carolina, 27695, United States

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Walking

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Central Study Contacts

Amay Bandodkar, PhD

CONTACT

9195150417; ajbandod@ncsu.edu

Ming Liu, PhD

CONTACT

9195158541; mliu10@ncsu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The participants are exposed to the two tasks in randomly decided sequence.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 14, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2029
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)