Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Behavioral: Therapist-Directed Re-loading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With or without peripheral neuropathy Able to safely exercise Have a recently closed plantar ulceration Exclusion Criteria: Presence of an open plantar ulceration Presence of an untreated infection Presence of osteomyelitis or gangrene

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapist-Directed Re-loading<br>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). | Behavioral: Therapist-Directed Re-loading<br>* 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.<br>|
| No Intervention: Self-Directed Re-loading<br>Participants in this arm will be instructed to slowly increase their walking. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, re-loading, ulcer recurrence