This study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. The people in this study will have diabetes and have a recently closed foot ulcer. About half will be specifically told how to return to walking and the other half will be told to return to walking slowly. How people naturally return to walking will also be established.
The purpose of this project is to determine the impact of Therapist-directed loading versus self-selected loading on ulcer occurrence and to establish natural loading behavior following diabetic foot ulcer closure. Eligible participants will be randomized into a group given specific directions from a Therapist to return to walking (i.e. reloading skin following plantar ulceration closure) or a group encouraged to slowly return to walking (self-directed re-loading of the skin following plantar ulceration closure). Following randomization and instruction for re-loading according to group assignment, participants will be assessed every 6 months for walking behavior. Participants will be monitored for ulcer recurrence throughout. Participants will be followed for up to 18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
Therapist will specifically direct participant to increase walking by 10% as measured at each of the activity monitoring assessments. In addition, the participant will be asked to monitor foot temperature to mitigate risk for breakdown.
Piedmont Healthcare
Atlanta, Georgia, United States
RECRUITINGIncidence of Ulcer Recurrence
Assessment of incidence of any plantarr ulcer recurrence.
Time frame: Over up to 18 months of follow-up.
Change in walking behavior (steps)
Actual assessment of change in walking behavior will be assessed by number of steps.
Time frame: Assessed initially and every 6 months for 1 week for up to 18 months.
Change in walking behavior (step timing)
Actual assessment of change in walking behavior will be assessed by the timing of steps (how many steps in a given timeframe).
Time frame: Assessed initially and every 6 months for 1 week for up to 18 months.
Exercise component of Summary of Diabetes Self-Care Activities Scale
Questionnaire to assess exercise adherence. It is a report of the number of days that an individual participates in physical activity as well as specific exercise (2 questions). The higher the number, the more days of activity/exercise participation. The more days of participation, the better the investigators would expect health to be.
Time frame: Assessed initially and every 6 months for up to 18 months
Bio-thesiometer
Assesses vibration sense
Time frame: Assessed initially and every 6 months for up to 18 months
Body Mass Index (BMI) and disease risk
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: Assessed initially and every 6 months for up to 18 months
Waist circumference
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Waist circumference (measured in cm) will be assessed for change over time.
Time frame: Assessed initially and every 6 months for up to 18 months