# Detecting Arch Instability in Charcot Neuropathy

> **NIH NIH R41** · INNOVATIVE SCIENTIFIC SOLUTIONS, INC. · 2020 · $141,394

## Abstract

Abstract
 Charcot neuropathy (CN) is a serious complication resulting from poorly controlled diabetes
and peripheral neuropathy that leads to the collapse, and ultimately the breakdown, of the
midfoot. Charcot occurs in approximately 0.08% of the general diabetic population, however the
prevalence increases to 13% in high-risk diabetic patients [1,2] and even 35% in patients with
polyneuropathy in industrialized countries [3]. In terms of treating CN patients, Chantelau et al.
[7] described the “perils of procrastination” and showed the effects of early versus delayed
detection of arch instability and collapse.
 The Cleveland State University (CSU) team recently identified an early detection concept
for arch instability [8] using a platform system for plantar shear and pressure measurements
produced by Innovative Scientific Solutions Inc. (ISSI). The study developed a metric (Sflatten)
to quantify arch instability that compared posterior shear under the heel with the anterior shear
under the first metatarsal head. Sflatten was significantly higher in neuropathic diabetics than in
controls. Unfortunately, the platform system limited the evaluation to barefoot plantar contact
patterns and a limited number of steps. Here we propose the next step in developing a tool for
detecting and monitoring arch instability, specifically, an in-shoe system that measures plantar
pressure and shear in normal footwear over multiple gait cycles. We believe that an in-shoe
system will also facilitate clinical deployment.
 Phase I will combine CSU’s arch collapse detection algorithms with ISSI’s new in-shoe
sensor technology. It will include benchtop calibration and validation of the in-shoe system and
comprehensive gait testing with a cohort of control subjects with varying arch indices. If
successful, Phase II will evaluate the system’s performance with diabetic and Charcot patients
and develop risk thresholds. The overall objective is to lay the groundwork for commercializing a
product that not only enables early diagnosis and monitoring of “Charcot foot”, but also
addresses the broad need to assess risk factors for skin breakdown under the feet of diabetic
patients.

## Key facts

- **NIH application ID:** 10010413
- **Project number:** 1R41DK125238-01
- **Recipient organization:** INNOVATIVE SCIENTIFIC SOLUTIONS, INC.
- **Principal Investigator:** Jim Wayne Crafton
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $141,394
- **Award type:** 1
- **Project period:** 2020-08-01 → 2021-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10010413

## Citation

> US National Institutes of Health, RePORTER application 10010413, Detecting Arch Instability in Charcot Neuropathy (1R41DK125238-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10010413. Licensed CC0.

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