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

Part of paid clinical trials in Raleigh, North Carolina.

Sponsor
North Carolina State University
Study ID
NCT07216183
Phase
PHASE1
Status
Recruiting
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Conditions

  • Transtibial Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 16, 2025
Status verified
Oct 2025
Primary completion
Jul 30, 2028
Completion
Jul 30, 2029

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Engineering Build IIIRaleighNorth Carolina27695
Ming Liu, PhD
[email protected]
919-515-8541

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Engineering Build III· Raleigh, NC

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