The Effect of Exercise on Wound Healing in People With Diabetes Undergoing Off-loading Treatment
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Mercer University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Wound measurement size
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
The outcome assessor will be unaware of how much the participant participated in the exercise program. Exercise will occur away from the treatment area so that the care provider will be unaware of whether or not a patient is participating in the study.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Exercise Added to Off-loading
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.
Intervention: Exercise (Behavioral)
Outcomes
Primary Outcomes
Wound measurement size
Time Frame: Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.
Charts will be reviewed for normal wound measurements as is part of standard care. Measurements are expected to be reported as surface area (cm\^2) and/or volume (cm\^3). Wound closure will be defined as epithelialization across the entire wound bed and would be expected to correlate to no surface area or volume of wound being reported.
Secondary Outcomes
- Physical activity data using an activity monitor (e.g. StepWatch).(Measured at baseline for one week.)
- Summary of Diabetes Self-Care Activities Scale(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
- Vibration sense(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
- Waist circumference(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
- Body Mass Index(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
Investigators
Deborah M. Wendland, Ph.D.
Associate Professor
Mercer University