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

  • End date
    Dec 2, 2023
  • participants needed
  • sponsor
    Mercer University
Updated on 2 November 2021
foot ulcer
plantar ulcers


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.

Condition Diabetic Foot, Diabetic Foot Ulcers, diabetic foot ulcer
Treatment Therapist-Directed Re-loading
Clinical Study IdentifierNCT04310137
SponsorMercer University
Last Modified on2 November 2021


Yes No Not Sure

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
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