Clinical trial NCT04310137: Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence
Official title: The Effect of Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes
re-loading
ulcer recurrence
Lead sponsor: Mercer University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Ulcer Recurrence
timeFrame: Over up to 18 months of follow-up.
measure: Change in walking behavior (steps)
timeFrame: Assessed initially and every 6 months for 1 week for up to 18 months.
measure: Change in walking behavior (step timing)
timeFrame: Assessed initially and every 6 months for 1 week for up to 18 months.
Secondary outcomes:
measure: Exercise component of Summary of Diabetes Self-Care Activities Scale
timeFrame: Assessed initially and every 6 months for up to 18 months
measure: Bio-thesiometer
timeFrame: Assessed initially and every 6 months for up to 18 months
measure: Body Mass Index (BMI) and disease risk
timeFrame: Assessed initially and every 6 months for up to 18 months
measure: Waist circumference
timeFrame: Assessed initially and every 6 months for up to 18 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
Study officials:
affiliation: Mercer University
name: Deborah M. Wendland
role: PRINCIPAL_INVESTIGATOR
References: