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NCT Number: NCT07216183

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.

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Key information

Conditions

Transtibial Amputation Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Engineering Build III

Raleigh, North Carolina, 27695, United States

Location status: Recruiting

Location contact

Ming Liu, PhD

CONTACT

[email protected]

919-515-8541

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Walk

Procedure

Treadmill walking

Yuga post

Procedure

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

E-SWEAT Sensor

Device

Mounting the E_SWEAT sensor to monitor the lactic density, pressure, and temperature inside the socket

Primary outcomes

  1. Lactic acid density

    Time frame: periprocedural in the first visit

    amount of lactic acid in sweat

Secondary outcomes

  1. Socket environment - temperature

    Time frame: periprocedural in the first visit

    temperature at the location where the E-SWEAT is mounted

  2. Socket environment - pressure

    Time frame: periprocedural in the first visit

    Pressure measured at the location where the E-SWAET is mounted

Other outcomes

  1. Body weight

    Time frame: At the beginning of the first visit

    Participants' body weight

Study contacts

Contact information is provided by the study sponsor or research team.

Amay Bandodkar, PhD

CONTACT

[email protected]

9195150417

Ming Liu, PhD

CONTACT

[email protected]

9195158541

Sponsors and collaborators

Lead sponsor

North Carolina State University

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 14, 2025
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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