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Recruiting NCT07216183

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

Phase I Interventional Transtibial Amputation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Walk, Yuga post, E-SWEAT Sensor.
Who it may be relevant to
Registry conditions: Transtibial Amputation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Walk
    Treadmill walking
  • Procedure Yuga post
    Participants conduct a yuga post which involves their efforts but not load on their residual limbs
  • Device E-SWEAT Sensor
    Mounting the E\_SWEAT sensor to monitor the lactic density, pressure, and temperature inside the socket

Primary outcome measures

  • Lactic acid density [Time frame: periprocedural in the first visit]
Secondary outcome measures (2)
  • Socket environment - temperature [Time frame: periprocedural in the first visit]
  • Socket environment - pressure [Time frame: periprocedural in the first visit]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Engineering Build III — Raleigh

Identifiers

NCT: NCT07216183 · 26923 · HT9425-24-1-0579

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗