Status:
RECRUITING
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
Lead Sponsor:
North Carolina State University
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Conditions:
Transtibial Amputation
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2029
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT07216183
Start Date
September 16 2025
End Date
July 30 2029
Last Update
October 14 2025
Active Locations (1)
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1
Engineering Build III
Raleigh, North Carolina, United States, 27695