Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
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 mai
| Condition(s) | Transtibial Amputation |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 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 mech |
| Who can participate | 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 con |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | North Carolina State University |
| Locations | Raleigh, North Carolina, United States |
| Start date | 2025-09-16 |
| NCT ID | NCT07216183 |
| Official listing | https://clinicaltrials.gov/study/NCT07216183 |