A Retrospective Pre-Commercial Case Series of 18 Patients Using the Empo Footprint Scale and Empo Remote Health Link Service

Purpose of the Study:

This retrospective case study analyzed data from a previously completed device usability study involving people with diabetes who used the Empo® Footprint Scale, a new in-home remote foot monitoring device. The goal of the previous usability study was to analyze the device’s usability and effectiveness with a group of standard users and podiatrists. The goal of this retrospective case study was to explore whether the Empo Footprint, in conjunction with the Empo® Remote Health Link service, encouraged patient adherence to prescribed use of the device and enabled clinicians to remotely identify early signs of diabetic foot ulcers (DFUs), a common and serious complication of diabetes that can result in amputation if not treated.

Description of the Empo Footprint:

The Empo Footprint device takes high-resolution full-color images of users’ feet at home. These are shared securely and automatically with healthcare providers, allowing for remote patient monitoring and potential early clinical intervention.

About the Usability Study:

Patients identified as representative end users were enrolled by their podiatrist into a device usability study that began in 2024 at one of three participating podiatry clinics. The device was installed in the patient’s home by Empo Health and after a 1-month study preparation period that included the initial device setup, the device was used by the patient for 6 months of data collection.

Who Participated in the Usability Study:

Patients meeting the following criteria were invited by their podiatrists to participate in the device usability study:

  1. Diagnosis of Type I or Type II diabetes
  2. Documented history of neuropathic foot ulcer
  3. Reliable Wi-Fi or reliable smartphone cell service in their home at the time of enrollment
  4. 18 years old or older at the time of consent
  5. Has a private email address or a private phone number capable of receiving text messages
  6. Ability to give informed consent to the study in English

Due to the usability study’s focus on determining a baseline of standard user interaction with the device, patients with any of the following criteria were excluded from participation:

  1. Full weight bearing cannot be achieved
  2. Bodyweight greater than 200 kg (440 lbs.)
  3. Inability to communicate in English
  4. Any condition or situation (self-reported or apparent) that, in the opinion of the study podiatrist, made the participant inappropriate for participation

The Usability Study Assessed:

  • How providers used images collected through the Empo Footprint and Empo Remote Health Link to detect and address early indications of DFUs.
  • How well the Empo Footprint performed in real-world, at-home settings.
  • If patients and doctors found the Empo Footprint and Empo Remote Health Link easy and effective to use.

Data from the Usability Study was collected via the Empo Remote Health Link web portal and surveys, with findings and metrics such as device usage, image quality, patient satisfaction scores recorded in a separate de-identified database.

About this Retrospective Case Study:

The retrospective case study analyzed de-identified data from the Usability Study to summarize patient satisfaction questionnaire responses, monthly device usage measured in days of use per month, and number of provider follow-up actions triggered by the device usage to explore whether the Empo Footprint, in conjunction with the Empo Remote Health Link service, encouraged patient adherence to prescribed use of the device and enabled clinicians to remotely identify early signs of DFUs.

Data from the Usability Study was de-identified both through the existing de-identified spreadsheet and a de-identified view of the Empo Remote Health Link portal. This de-identified data was analyzed for this retrospective case study.

How the Study Was Conducted:

No new patient interactions were involved. The analysis was based entirely on pre-existing data collected during the campaign. The dataset was de-identified prior to analysis to protect participant privacy.

Data Reviewed:

Descriptive statistics (means, standard deviations, frequency counts, and percentages) were calculated, as appropriate, for:

  • Demographics (age, gender, etc.)
  • Foot images
  • Device usage patterns
  • Medical history related to diabetes and foot health
  • User and physician feedback

Results:

Participants used their devices for 27 median days/month, with months defined as consecutive 30-day windows. Early indications of DFUs were detected by podiatrists for 8 out of 18 participants.

These results are from the continuous 6 month in-home imaging device and remote monitoring platform usage data from 18 diabetic adults (43 to 86 years old) and their three podiatrists. These results represent a subset of data from a longer product testing period, portions of which are currently pending publication.

Limitations:

  • Participants were recruited from a limited number of podiatry clinics and received free use of the device in exchange for participating in the campaign.
  • The data analyzed was collected during a market research campaign, not a controlled clinical trial, which may impact the generalizability and rigor of the findings.
  • The study excluded non-English speakers and allowed subjective exclusion by podiatrists for any reason (primarily intended to ensure that the podiatrists could exclude a subject if they felt they could not use the device safely), which, combined with the limited diversity of participants (primarily English-speaking Caucasian men), may impact the representativeness and generalizability of the findings to broader populations.

Associated Risks:

There were no known risks to participants from this retrospective case study. Participation agreements, including HIPAA waivers, were executed for all participants prior to their enrollment in the study. This analysis received a waiver of consent from Advarra IRB.

Disclaimer:

The three podiatrists who participated in this study were compensated by Empo Health on an hourly basis and per patient recruited to account for their time contributing to the study. Compensation was based solely on time spent and was not tied to study performance or outcomes. Each participating podiatrist also serves as a clinical advisor and holds equity in the company.