Diabetic Foot Ulcer
Conditions
Keywords
Diabetes, re-loading, ulcer recurrence
Brief summary
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
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.
Interventions
BEHAVIORALTherapist-Directed Re-loading
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.
Sponsors
Mercer University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will be unaware of in which group the participant was randomized.
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ulcer Recurrence | Over up to 18 months of follow-up. | Assessment of incidence of any plantarr ulcer recurrence. |
| Change in walking behavior (steps) | Assessed initially and every 6 months for 1 week for up to 18 months. | Actual assessment of change in walking behavior will be assessed by number of steps. |
| Change in walking behavior (step timing) | Assessed initially and every 6 months for 1 week for up to 18 months. | Actual assessment of change in walking behavior will be assessed by the timing of steps (how many steps in a given timeframe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise component of Summary of Diabetes Self-Care Activities Scale | Assessed initially and every 6 months for up to 18 months | 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. |
| Waist circumference | Assessed initially and every 6 months for up to 18 months | Waist circumference (measured in cm) will be assessed for change over time. |
| Bio-thesiometer | Assessed initially and every 6 months for up to 18 months | Assesses vibration sense |
| Body Mass Index (BMI) and disease risk | Assessed initially and every 6 months for up to 18 months | Weight and height will be combined to report BMI in kg/m\^2. |
Countries
United States
Contacts
Primary ContactDeborah M. Wendland, PhD
Backup ContactTeri Biven, DPT
Outcome results
None listed