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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapist-Directed Re-loading | Experimental | Participants in this arm will be instructed to increase their activity by walking 10% more steps per day than the steps recorded in the most recent activity monitoring (i.e. StepWatch) measurement (e.g. 10% more than the initial monitoring values and 10% more than the second monitoring values once they are completed). |
|
| Self-Directed Re-loading | No Intervention | Participants in this arm will be instructed to slowly increase their walking. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapist-Directed Re-loading | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Ulcer Recurrence | Assessment of incidence of any plantarr ulcer recurrence. | 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. | 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). | Assessed initially and every 6 months for 1 week for up to 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah M. Wendland, PhD | Contact | 6785476775 | wendland_dm@mercer.edu | |
| Teri Biven, DPT | Contact | 404.605.2743 | teri.biven@piedmont.org |
| Name | Affiliation | Role |
|---|---|---|
| Deborah M. Wendland | Mercer University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Healthcare | Recruiting | Atlanta | Georgia | 30309 | United States |
De-identified step data will be made available through a repository upon conclusion of the study and its dissemination.
Data will be available following the study conclusion and its dissemination (6 months after publication).
This information will be shared with researchers for meta-analyses through the data repository.
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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Randomized Controlled Trial
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The outcome assessor will be unaware of in which group the participant was randomized.
|
| Assessed initially and every 6 months for up to 18 months |
| Bio-thesiometer | Assesses vibration sense | 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. | Assessed initially and every 6 months for up to 18 months |
| Waist circumference | Waist circumference (measured in cm) will be assessed for change over time. | Assessed initially and every 6 months for up to 18 months |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |