Recruiting
Phase 1

E-SWEAT System

Sponsor:

North Carolina State University

Code:

NCT07216183

Conditions

Transtibial Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Walk

Yuga post

E-SWEAT Sensor

Study Details

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

Study ID

NCT07216183

Start date

Sep 16, 2025

Status verified date

Oct, 2025

Completion date

Jul 30, 2029

Anticipated

Primary completion date

Jul 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Normal walking

Participants walk on a treadmill with user preferred speed.

active comparator: No load excise - Yuga post

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

Interventions

Walk

Treadmill walking

Yuga post

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

E-SWEAT Sensor

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

Primary outcome measure

  • Lactic acid density [ Time Frame: periprocedural in the first visit ]

Central Contacts and Locations

Central contacts

Amay Bandodkar, PhD

9195150417ajbandod@ncsu.edu

Ming Liu, PhD

9195158541mliu10@ncsu.edu

Locations

Engineering Build III

Recruiting

Raleigh, North Carolina, United States, 27695

Contacts

Ming Liu, PhD

919-515-8541mliu10@ncsu.edu

More Information

Sponsor

North Carolina State University

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Carolina State University on 2025-10-14.