# Pressure Alternating Shoes for Prevention of Diabetic Foot Ulcers

> **NIH NIH R21** · UT SOUTHWESTERN MEDICAL CENTER · 2020 · $229,480

## Abstract

ABSTRACT
Diabetic foot ulcers continue to burden the US healthcare system and patients with an estimated annual cost of
$30 billion and amputation rates of 100,000. The exact etiology of the problem remains to be resolved, though
it is known to be multi-factorial. Diabetic foot lesions have a biomechanical pathology that involves mechanical
stresses acting under the foot; however, foot pressure alone is not a good predictor of ulcers, since ulcers are
known to occur at pressure levels that are not considered harmful. Results regarding the pathological effects of
plantar shear are not yet conclusive. Preventive footwear, designed to address only peak pressures have
shown poor success in preventing ulceration, which further indicates that the pathology is multi-factorial. An
alternative theory regarding ulceration states that diabetic peripheral neuropathy leads to unvarying patterns of
plantar loading in diabetic patients, which may consequently result in tissue tenderness and breakdown.
Healthy individuals have been shown to shift their loading patterns based on sensory feedback, which prevents
tissue tenderness and pain at the regional scale. Due to neuropathy, certain regions of the diabetic foot are
thought to experience repetitive stresses that are not relieved in response to discomfort or pain that these
stresses would create. Prolonged repetition might result in failure of the tissue even with lower, yet unrelieved,
mechanical stresses. Developing effective footwear and intervention strategies to prevent diabetic amputations
requires a comprehensive approach which addresses multiple causative factors of foot ulceration and allows
for the study of these unrelieved repetitive stresses. In this study, we will develop pressure alternating shoes
(PAS) that will provide selective rest to the plantar aspect of the foot in order to prevent diabetic ulcers. The
ultimate aim of this footwear will be to limit repetition of local plantar stresses, particularly at peak stress sites,
and provide tissue an opportunity to recover. This periodic off-loading will also help prevent ischemic
conditions in the plantar tissue, particularly in diabetic patients who stand for a long time. We will design and
test the PAS to achieve the selective rest function and evaluate its safety, usability, biomechanical
characteristics and comfort with healthy and diabetic subjects. This will be the first study on the effect of a
device actively modulating the mechanical loading at the plantar surface for foot ulcer prevention and will allow
for a systematic study of cyclical mechanical loading effects on foot ulcer formation which will advance
understanding in the field of diabetic foot care. Ultimately, such a study has the potential to significantly impact
the long term care of diabetics with a high prevalence of foot ulceration and improve their quality of life.

## Key facts

- **NIH application ID:** 10013112
- **Project number:** 7R21AG061471-02
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** LAWRENCE A LAVERY
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $229,480
- **Award type:** 7
- **Project period:** 2019-09-15 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10013112

## Citation

> US National Institutes of Health, RePORTER application 10013112, Pressure Alternating Shoes for Prevention of Diabetic Foot Ulcers (7R21AG061471-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10013112. Licensed CC0.

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