The Effect of Exercise on Wound Healing While Off-loading

Not Applicable

• Conditions: Diabetic Foot Ulcer
• Interventions: Behavioral: Exercise

• Registration Number: NCT04280016
• Lead Sponsor: Mercer University

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 Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2021-05-14
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-25
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Added to Off-loading	Exercise	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.

Primary Outcome Measures

Name	Time	Method
Wound measurement size	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 Outcome Measures

Name	Time	Method
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).	Participation in exercise. Using two questions, this scale measures the number of days that an individual reports doing physical activity (question 1) or specific exercise (question 2). Scores on each question could range from 0 to 7 days. The higher the number, the more days the individual participates in the activity or exercise.
Physical activity data using an activity monitor (e.g. StepWatch).	Measured at baseline for one week.	A week-long measurement of strides will be taken at the begin of the study.
Vibration sense	Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).	Vibration sense will be measured using a Bio-Thesiometer to assess for degree of peripheral neuropathy. A higher score would indicate decreased sensory perception of vibration.
Waist circumference	Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).	Waist circumference will be taken in cm as a marker of body composition.
Body Mass Index	Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).	Height and weight measurements will be combined and reported as BMI and measured in kg/m\^2.

Trial Locations

Locations (1)

Piedmont Healthcare; 🇺🇸 Atlanta, Georgia, United States