# Home-monitoring system for Lower Extremity Amputation Prevention (LEAP) for patients with diabetes at high risk of ulceration

> **NIH NIH R43** · ARCHE HEALTHCARE LLC · 2020 · $206,149

## Abstract

Home-monitoring system for Lower Extremity Amputation Prevention (LEAP) for patients with diabetes
 at high risk of ulceration: Project Summary
 Foot ulceration, often on the plantar surface, is the most common and costly late complication of
diabetes (1-4), with morbidity and mortality being worse than many cancers. In 2014, diabetic foot ulcers
(DFUs) cost Medicare an estimated $18.7 billion (5,6). Pathways to ulceration are well defined: peripheral
neuropathy results in insensitivity, and repetitive stress on high pressure areas leads to inflammation and
warming, thus the foot warms up before it breaks down, often without warning symptoms (1,3,7). Due to loss of
sensation, patients have poor appreciation of their DFU risk, resulting in a lack of preventive foot self-care (8).
Information-alone focused education that does not allow patients to visualize and monitor their DFU risk has
not succeeded in reducing the incidence of ulceration (9) In contrast, education together with patient self-foot-
temperature monitoring, can lead to a reduction in recurrent ulcer incidence (10,11). Lavery et al confirmed that
self-foot temperature monitoring in those with past DFU is associated with a significant reduction in new DFU
compared to standard of care (11). A recent study using remote self-foot temperature monitoring showed that
an asymmetry of 2.2°C between the two feet of patients with a DFU history predicted 97% of DFU recurrence
(12) and reported promising levels of adherence to self-monitoring.
 Arche Healthcare’s tools and technology are designed to increase patients’ recognition of their DFU risk
by literally making it visible to them, and to increase monitoring adherence by using technology prompts rather
than relying solely on patient self-motivation. Arche Healthcare’s current foot temperature home-monitoring
device, TempStat®, allows for easy identification of areas of elevated temperature (13). Using patented liquid
crystal thermography (LCT), the leading technology (14), TempStat takes about 60 seconds to produce a
thermal image of the soles of the feet. An embedded mirror allows for visual inspection by the patient. Building
on this user-friendly foot temperature monitoring device, Arche Healthcare plans to revolutionize home diabetic
foot screening by integrating two components into the existing OPTYX® clinical information system: The
Insight® hardware device (modified TempStat) and the VeriSole® mobile application (app). In the InSight
device, the mirror will be replaced with a scanner that will transmit an image of the bottoms of the patient’s feet
to their phone or tablet via VeriSole. The app will track adherence to daily foot temperature monitoring and
incidences of skin temperature elevation, and will alert the patient and their provider, through their dashboard
in Arche’s OPTYX proprietary clinical information system, as to imminent DFU risk. If the patient fails to monitor
and/or take an appropriate action in response to a ‘hot s...

## Key facts

- **NIH application ID:** 10154607
- **Project number:** 1R43DK126592-01A1
- **Recipient organization:** ARCHE HEALTHCARE LLC
- **Principal Investigator:** Andrew JM Boulton
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $206,149
- **Award type:** 1
- **Project period:** 2020-09-16 → 2022-09-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10154607

## Citation

> US National Institutes of Health, RePORTER application 10154607, Home-monitoring system for Lower Extremity Amputation Prevention (LEAP) for patients with diabetes at high risk of ulceration (1R43DK126592-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10154607. Licensed CC0.

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