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

Mercer University

Status: Unknown

Conditions: Diabetic Foot Ulcer

Treatments: Behavioral: Therapist-Directed Re-loading

Study type: Interventional

Funder types: Other

Identifiers

NCT04310137

H1908191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Therapist-Directed Re-loading

Experimental group

Description:

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).

Treatment:

Behavioral: Therapist-Directed Re-loading

Self-Directed Re-loading

No Intervention group

Description:

Participants in this arm will be instructed to slowly increase their walking.