# Home-based exercise to improve functional outcomes in Veterans with recently healed diabetic foot ulcer

> **NIH VA I21** · BALTIMORE VA MEDICAL CENTER · 2024 · —

## Abstract

Foot ulcers are a common and feared complication for people with diabetes. Each year one in twenty
people with diabetes develop a foot ulcer. One in five foot ulcers will become infected leading to lower
extremity amputation. The burden of diabetic foot ulcers is not equal across groups. Ulcers are more common
and have higher amputation rates in Black, Hispanic, and other non-White people.
 The pathway to ulceration is well established and involves multiple co-morbid conditions. People with
diabetes develop peripheral neuropathy and can have inadvertent trauma to their foot. The resulting wound
fails to heal, in part, because of peripheral arterial disease and poor glycemic control. People with a diabetic
foot ulcer also have a higher risk of dying within five years than people with diabetes, matched for co-
morbidities, without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years,
largely due to cardiovascular causes. The reasons for this accelerated mortality are not well defined but likely
involve disuse and inflammation. Part of ulcer treatment is to take pressure off the ulcer, known as off-loading.
This leads to prolonged loss of mobility as treatment takes months.
 People with a recently healed diabetic foot ulcer are considered “in remission” as opposed to “cured”
because the underlying co-morbidities which led to their ulcer are still present. Once in remission, the current
standard of care is to slowly increase ambulation with appropriate footwear, so as not to promote ulcer
recurrence. The problem is that people rarely return to the recommended level of mobility. The ability to safely
maintain mobility with aging is critical. Although there are ongoing studies of the effect of exercise on ulcer
healing, we are aware of only one small, non-U.S. based clinical trial on exercise during “remission”. This is
likely because this population is typically excluded from exercise interventions. Like a person who has recently
recovered from a heart attack, this is a critical time to intervene to improve mobility and safely restore function
to improve long term outcomes.
 We hypothesize that a home-based exercise regimen will increase mobility and function without
increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue
perfusion and glycemic control. In a clinical trial to assess feasibility and acceptability in a diverse population,
we will randomize 25 Veterans with a recently healed diabetic foot ulcer to a 12-week home-based exercise
regimen or standard of care in a 3:1 ratio. The intervention is purposefully home-based to maximize access to
care. [Our primary objectives are to assess acceptability and feasibility of the intervention and estimate the
effect of the intervention on gait speed.] Our secondary objective is to estimate the effect of the intervention on
mobility and function including six-minute walk distance, the Modified Physical Performance ...

## Key facts

- **NIH application ID:** 10923447
- **Project number:** 1I21RX004897-01A1
- **Recipient organization:** BALTIMORE VA MEDICAL CENTER
- **Principal Investigator:** Mary-Claire Roghmann
- **Activity code:** I21 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2024-07-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10923447

## Citation

> US National Institutes of Health, RePORTER application 10923447, Home-based exercise to improve functional outcomes in Veterans with recently healed diabetic foot ulcer (1I21RX004897-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10923447. Licensed CC0.

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