The Effect of Exercise on Wound Healing While Off-loading

Mercer University

Status: Unknown

Conditions: Diabetic Foot Ulcer

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04280016

H1908192

Details and patient eligibility

About

This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.

Full description

The purpose of this project is to establish the effect of the addition of exercise to an off-loading intervention on the healing time for people with diabetes mellitus and a foot ulcer.

While benefits of physical activity and exercise are clear, the benefit of exercise on wound healing in individuals with diabetes has not been elucidated. It is critical to better understand how prescribed exercise effects the healing speed in patients receiving wound care with appropriate off-loading. If exercise does decrease healing time, the benefit to the patient may include lower cost, decreased risk of infection, decreased burden on a caregiver, and improved quality of life.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have diabetes
• Have an active plantar ulceration
• With or without peripheral neuropathy
• Able to safely exercise
• Receiving care for their plantar ulceration, including off-loading

Exclusion criteria

• Presence of an untreated infection, osteomyelitis, or gangrene

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Exercise Added to Off-loading

Experimental group

Description:

Participants in this arm will participate in exercise at the healthcare facility one time a week (away from where wound care is provided) and be instructed in a home exercise program that they will be encouraged to perform at least three days per week with no more than two days between sessions. Wound care will continue at the facility as is standard, utilizing off-loading.

Treatment:

Behavioral: Exercise