E-SWEAT wearable sensors to monitor residual limb health
Official title: Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
Run by North Carolina State University · NCT07216183 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | North Carolina State University Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Status | Recruiting |
| Started | September 16, 2025 |
| Main results expected | July 30, 2028 |
| Study ends | July 30, 2029 |
| Registry record updated | October 14, 2025 |
| Trial ID | NCT07216183 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Engineering Build III
Raleigh, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Amay Bandodkar, PhD
- Email: ajbandod@ncsu.edu
- Phone: 9195150417
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Footwear effects on walking in people with a leg prosthesis
This study tests four different types of footwear to see how they affect walking in adults with a unilateral transtibial amputation who use a prosthetic foot.
-
Access Socket: a flexible prosthetic socket for transtibial amputation
This trial tests whether the Access Socket, a hybrid flexible socket, improves comfort and function for adults with transtibial amputations compared with standard rigid sockets.
-
Improving prosthetic socket fit for veterans with lower limb amputations
This study is testing whether an adjustable prosthetic socket can help veterans with lower limb amputations walk better and feel more comfortable compared to a regular socket.
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How prosthetic foot stiffness affects outcomes after a below-knee amputation with bone-anchored or socket prostheses
This trial will test whether using a softer, your usual, or a stiffer prosthetic foot changes comfort, walking function, and bone‑implant loading for adults with a single below‑knee amputation who use either a bone‑anchored limb or a socket prosthesis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.