Actively Recruiting
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
Led by North Carolina State University · Updated on 2025-10-14
16
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
N
North Carolina State University
Lead Sponsor
U
University of North Carolina, Chapel Hill
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older
- Have a unilateral lower limb amputation below the knee with tibial length on the residual limb greater than half the length of the unaffected side
- Have had the amputation over 2 years ago
- Have at least 1 year of experience using a prosthetic leg
- Have used the current prosthetic socket for at least 6 months without significant skin issues or major modifications
- Be able to walk comfortably for 6 minutes with the prosthetic leg without pausing to rest
- Be willing to come to North Carolina State University's Centennial Campus and be photographed during research activities
You will not qualify if you...
- Have cognitive or visual impairments affecting consent or ability to follow instructions
- Have any neuropathy on the residual limb
- Experience numbness, tingling, muscle weakness, or pain in the residual limb
- Weigh more than 300 pounds
- Do not want to be photographed
- Are pregnant or plan to become pregnant
- Are allergic to latex
- Use medications to control sweat on the residual limb and cannot avoid them for 48 hours as approved by your medical provider
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Engineering Build III
Raleigh, North Carolina, United States, 27695
Actively Recruiting
Research Team
A
Amay Bandodkar, PhD
CONTACT
M
Ming Liu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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