The Effect of Exercise on Wound Healing While Off-loading

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.

Official Title
-----------------
The Effect of Exercise on Wound Healing in People With Diabetes Undergoing Off-loading Treatment

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A pilot study using retrospective chart review and non-randomized controlled trial methodology (single group).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Added to Off-loading<br>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. | Behavioral: Exercise<br>* Participants will participate in an exercise session with non-weight-bearing exercise that the participant is able to perform with off-loading (e.g. total contact cast) intact. They will also be instructed in a home exercise program so that exercise can be performed three days per week with no more than two days between sessions. These participants will also receive standard wound care with off-loading.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound measurement size | 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. | Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Diabetes Self-Care Activities Scale | 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. | Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first). | 
| Body Mass Index | Height and weight measurements will be combined and reported as BMI and measured in kg/m^2. | Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first). | 
| Physical activity data using an activity monitor (e.g. StepWatch). | A week-long measurement of strides will be taken at the begin of the study. | Measured at baseline for one week. | 
| Vibration sense | 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. | Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first). | 
| Waist circumference | Waist circumference will be taken in cm as a marker of body composition. | Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, off-loading, exercise