E-SWEAT Sensor for Below Knee Amputation

This trial tests a new sensor, the E-SWEAT, to determine if it can measure pressure, temperature, and lactic acid density in sweat for individuals with below-knee amputations. The study aims to discover whether lactic acid levels in sweat increase with more pressure on the limb, such as during walking. Participants will engage in two activities: walking and a yoga pose that does not put weight on the limb. Ideal participants have used a below-knee prosthetic for at least a year and can walk comfortably for 6 minutes. As a Phase 1 trial, this research focuses on understanding how the E-SWEAT sensor functions in people, offering participants the chance to be among the first to experience this innovative technology.

If you are using medication to control sweat on your residual limb, you may need to stop taking it for 48 hours if your medical provider approves. Otherwise, the trial does not specify stopping other medications.

Research shows that the E-SWEAT Sensor is a safe and non-invasive device for people with below-knee amputations. This sensor measures pressure, temperature, and lactic acid levels in sweat. Similar wireless skin sensors have been used in past studies and were well-tolerated by users, with no serious side effects reported. This suggests that the E-SWEAT Sensor should also be safe for participants.

Researchers are excited about the E-SWEAT Sensor because it offers a new way to monitor the health of the skin on the residual limb of individuals with below-knee amputations. Unlike traditional methods that might rely on visual inspections or patient-reported symptoms, this sensor can provide real-time data about sweat levels, which can indicate skin health and potential issues before they become serious. By allowing for more precise and proactive management, the E-SWEAT Sensor could significantly improve quality of life and reduce complications for amputees.

Research shows that the E-SWEAT Sensor is designed to measure pressure, temperature, and lactic acid levels in sweat for individuals with lower limb amputations. Early results suggest these sensors can effectively monitor these factors inside prosthetic sockets. This trial will evaluate the E-SWEAT Sensor under different conditions, including a "No load exercise - Yoga post" arm and a "Normal walking" arm. Monitoring is crucial because higher lactic acid levels might indicate increased pressure on the limb, affecting comfort and health. Tracking these changes aims to enable adjustments that improve prosthetic fit and function, reducing discomfort or injury risk. Although human studies have provided limited data, the technology appears promising for better understanding and managing pressure in prosthetic limbs.¹⁶⁷⁸⁹