E-SWEAT wearable sensors to monitor residual limb health
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
This trial tests a wearable sensor system that measures pressure, temperature, and lactic acid in sweat inside prosthetic sockets for adults with below-knee (transtibial) amputations.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | North Carolina State University Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT07216183 on ClinicalTrials.gov |
What this trial studies
The E-SWEAT project uses thin epidermal sensors placed on the residual limb inside the prosthetic socket to continuously record mechanical pressure, temperature, and lactic acid density in sweat. Participants with unilateral transtibial amputations will wear the sensors while performing a walking task that loads the residual limb and a yoga 'birddog' pose that does not load the limb. Sensor data from the two activities will be compared to determine feasibility of simultaneous monitoring and to see whether higher pressure exposure is associated with increased lactic acid density in sweat. Results will inform whether the device can reliably capture mechanical and biochemical markers relevant to socket fit and skin health.
Who should consider this trial
Good fit: Ideal participants are adults with a unilateral transtibial amputation (amputation >2 years ago), at least one year of prosthesis use, current socket used ≥6 months, a residual tibial length greater than half the unaffected side, able to walk six minutes with their prosthesis, and willing to attend sessions at NC State.
Not a fit: People with neuropathy, numbness, tingling, muscle weakness, residual limb pain, cognitive or visual impairments that affect consent or task following, bilateral amputations, or very recent amputations (<2 years) are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the sensors could help detect harmful socket pressures and sweat biomarker changes early, guiding adjustments to reduce skin breakdown and pressure ulcers.
How similar studies have performed: Wearable epidermal sensors and sweat-based biomarkers have shown feasibility in other populations, but applying them inside prosthetic sockets for amputees is novel and only partially supported by prior work.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Raleigh, North Carolina
- Engineering Build III — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Amay Bandodkar, PhD
- Email: ajbandod@ncsu.edu
- Phone: 9195150417
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.