Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1

North Carolina State University

Status and phase

Enrolling

Phase 1

Conditions

Transtibial Amputation

Treatments

Device: E-SWEAT Sensor

Procedure: Yuga post

Procedure: Walk

Study type

Interventional

Funder types

Other

Identifiers

NCT07216183

HT9425-24-1-0579 (Other Grant/Funding Number)

26923

Details and patient eligibility

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. 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.

Enrollment

16 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.