Home-based exercise to improve functional outcomes in Veterans with recently healed diabetic foot ulcer
Funded Grant
Overview
Affiliation
View All
Overview
description
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 Test, steps per day and community mobility. Our exploratory objective will estimate the effect of the intervention on lower extremity strength, perfusion of the foot and glycemic control. Our statistical hypothesis is that the changes in outcome measures will be greater in the intervention arm compared with the control arm. Our short-term goal in this pilot study is to assess whether an acceptable, home-based exercise regimen can be developed for Veterans with a recently healed diabetic foot ulcer. Our proposed project has clear potential for translation to clinical rehabilitation as a [telehealth group intervention] and could potentially have a high impact on a population with a history of health disparities. If successful, our exercise intervention will be tested in a future multi-site randomized clinical trial of people with a recently healed diabetic foot ulcer to assess whether it: 1) increases mobility and function; 2) decreases major adverse cardiovascular events; and 3) decreases long-term ulcer recurrence. Our long-term goal is to improve functional outcomes for Veterans with diabetic foot ulcer by improving their treatment and rehabilitation.
