# Thermal Imaging Modality for Detection of Large and Small Fiber Diabetic Peripheral Neuropathy.

> **NIH NIH R44** · VISIONQUEST BIOMEDICAL INC · 2020 · $989,109

## Abstract

Summary
Diabetic peripheral neuropathy (DPN) is a common, worldwide complication of diabetes mellitus
(DM). According to the CDC statistics for year 2017, 30.2 million Americans were reported to
have diabetes with 1.4 million new diabetic cases diagnosed every year. At least 50% of patients
with diabetes will develop DPN sometime in their lives, and up to 20% have DPN at the time of
diabetes diagnosis. DPN can result in foot or limb amputations in 15% of diabetics, with 82,000
lower extremity amputations occurring in the US annually. Therefore, an accurate means to detect
the presence of early-stage DPN is critically needed to improve outcomes when intervention is
most effective.
VisionQuest Biomedical has assembled a team of collaborators representing an inter-disciplinary
group of scientists with considerable experience in automated thermal image analysis, diabetes
comorbidity diagnosis and treatment, and specialized research in DPN and podiatry. This team
will continue to develop and test i-RxTherm ™, our patented device based on the principle that
skin blood flow is regulated by several neuronal factors that are affected by diabetes, which in
turn, alter the thermoregulation process in DPN patients. This approach enables the detection of
the effect of small or large fiber neuropathy. i-RxTherm integrates a thermal imaging camera and
a fully automated thermal image analysis software, that will increase the diagnostic accuracy for
DPN, leading to a smaller number of DPN patients that are otherwise missed by the currently
available clinical tools. The core innovation of i-RxTherm is its ability to detect any type of DPN,
namely small and large fiber DPN, a capability that no other single device currently has and one
that will allow it to become the standard of care for DPN screening among physicians.
In Phase II, we developed image analysis software to detect DPN using thermal videos of plantar
foot that demonstrated excellent performance with sensitivity of 85% and specificity of 75%.
Driven by the Phase II success, the main objective of Phase IIB is to put the devise on a commercial
path through a productization process that will make it ready for widespread use in screening.
At the end of this project, i-RxTherm will be at a commercial readiness stage where interest from
third party investors is maximized. We will accomplish these goals through the following specific
aims: 1) Design and build a portable device suitable for FDA testing and validate its intended
use. iRxTherm will be tested non-interventionally at our collaborator’s facility, the University of
New Mexico’s Clinical & Translational Science Center; 2) Conduct a clinical study to validate the
commercial iRxTherm. The clinical study will enroll a cohort of N =336 subjects diagnosed with
diabetes. This sample size is determined based on a statistical power analysis to reject the null
hypothesis of our primary end point (sensitivity/specificity of <85%/75%).
By the end of Year 2 of t...

## Key facts

- **NIH application ID:** 10007575
- **Project number:** 2R44DK104578-04A1
- **Recipient organization:** VISIONQUEST BIOMEDICAL INC
- **Principal Investigator:** David S Schade
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $989,109
- **Award type:** 2
- **Project period:** 2015-07-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10007575

## Citation

> US National Institutes of Health, RePORTER application 10007575, Thermal Imaging Modality for Detection of Large and Small Fiber Diabetic Peripheral Neuropathy. (2R44DK104578-04A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10007575. Licensed CC0.

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