NCT07216183 · North Carolina State University
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
What this study 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.
View original scientific description
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.
Interventions
PROCEDURE
Walk
Treadmill walking
PROCEDURE
Yuga post
Participants conduct a yuga post which involves their efforts but not load on their residual limbs
DEVICE
E-SWEAT Sensor
Mounting the E\_SWEAT sensor to monitor the lactic density, pressure, and temperature inside the socket
Primary outcome measures
Lactic acid density
Time frame: periprocedural in the first visit
amount of lactic acid in sweat
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Raleigh, North Carolina
Collaborators
University of North Carolina, Chapel Hill
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 14, 2025 · Source of record for eligibility and locations