Recruiting

Smart Insoles

Sponsor:

Spectrum Ergonomics and Occupational Health Services

Code:

NCT07273422

Conditions

No Applicable Condition; Study of Physiologic Monitor Alarms

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Observational with data collected

Study Details

Brief summary:

This study will evaluate the effectiveness of newly developed self-powered, smart insoles that will be used for remote patient monitoring (RPM) for both military and civilian populations. The present study is part of a project funded by SEMI and the Air Force Research Laboratory (AFRL).

Conditions

No Applicable Condition; Study of Physiologic Monitor Alarms

Study ID

NCT07273422

Start date

Jun, 2026

Status verified date

Nov, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Participant is generally health and between 18 and 90 year of age at time of signing consent.
2. Participant must be available for 4 visits to Spectrum Ergonomics over a 4-week period, one visit per week.

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Exclusion Criteria:

  • Age of Participants: 18-90

Sample Size:

At Utah:

All Centers: 120

Inclusion Criteria:

Inclusion criteria for Phase 1 and Phase 2 pilot studies at UofU

1\. Participant is generally healthy and between 18 and 90 years of age at time of signing consent 2. Participant must be able to walk comfortably for 1 mile. 3. Will seek 5 male and 5 female participants. Inclusion criteria for Phase 2 field studies conducted by Spectrum Ergonomics

1. Participant is generally health and between 18 and 90 year of age at time of signing consent.
2. Participant must be available for 4 visits to Spectrum Ergonomics over a 4-week period, one visit per week.

Exclusion Criteria:

Exclusion Criteria for Phase 1 and Phase 2 pilot studies at UofU

  • Flat feet (Pes planus)
  • Unilateral leg amputee
  • Females who are pregnant, < 3 months postpartum, or currently lactating.
  • Major surgery < 6 months or minor surgery < 3 months before enrollment.
  • Major infections such as sepsis or pneumonia < 3 months before enrollment.
  • Myocardial infarction or heart failure < 5 years or less before enrollment.
  • Ankle fusion or total replacement
  • Morbid obesity BMI > 40.

Exclusion Criteria for Phase 2 field study at Spectrum Ergonomics

  • Flat feet (Pes planus) or high arches (Pes cavus)
  • Unilateral leg amputee.
  • Brittle Diabetes- hard-to-control diabetes (also called labile diabetes), which is characterized by wide variations in blood glucose in which blood glucose levels can quickly move from too high (hyperglycemia) to too low (hypoglycemia).
  • Peripheral neuropathy.
  • Loss of sensation in the sole of foot.
  • Open wound on the foot.
  • Females who are pregnant, < 3 months postpartum, or currently lactating.
  • Ankle fusion or total replacement
  • Major surgery < 6 months or minor surgery < 3 months before enrollment.
  • Major infections such as sepsis or pneumonia < 3 months before enrollment.
  • Myocardial infarction or heart failure < 1 years before enrollment.
  • Morbid obesity BMI > 40.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Males and female ages 18-100 years old and ambulatory

Interventions

Observational with data collected

Observational with data collection from sensors in insole

Primary outcome measure

  • The present study is intended to evaluate the safety of the sensors embedded in the smart insoles and their accuracy in measuring biomarkers. [ Time Frame: "From enrollment to the end of observations at 4 weeks" ]

Central Contacts and Locations

Central contacts

Locations

Spectrum Ergonomics and Occupational Health Services

Recruiting

Williamsport, Pennsylvania, United States, 17701

Contacts

Principal Investigator:

Jeff Hiserman, Bachelor's

More Information

Sponsor

Spectrum Ergonomics and Occupational Health Services

Last update posted

Dec 9, 2025

Last verified

Nov, 2025

Keywords

  • remote patient monitoring, energy harvesting,

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spectrum Ergonomics and Occupational Health Services on 2025-12-09.