NCT04310137

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mercer University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
BEHAVIORAL	Therapist-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.

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-03-17
• Last updated: 2021-10-25

Locations

1 site across 1 country: United States