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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310137
• Other study ID #: H1908191
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: October 2021
• Source: Mercer University
• Contact: Deborah M. Wendland, PhD
• Phone: 6785476775
• Email: wendland_dm[@]mercer.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Recurrence
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Piedmont Healthcare	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Mercer University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Ulcer Recurrence	Assessment of incidence of any plantarr ulcer recurrence.	Over up to 18 months of follow-up.
Primary	Change in walking behavior (steps)	Actual assessment of change in walking behavior will be assessed by number of steps.	Assessed initially and every 6 months for 1 week for up to 18 months.
Primary	Change in walking behavior (step timing)	Actual assessment of change in walking behavior will be assessed by the timing of steps (how many steps in a given timeframe).	Assessed initially and every 6 months for 1 week for up to 18 months.
Secondary	Exercise component of Summary of Diabetes Self-Care Activities Scale	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.	Assessed initially and every 6 months for up to 18 months
Secondary	Bio-thesiometer	Assesses vibration sense	Assessed initially and every 6 months for up to 18 months
Secondary	Body Mass Index (BMI) and disease risk	Weight and height will be combined to report BMI in kg/m^2.	Assessed initially and every 6 months for up to 18 months
Secondary	Waist circumference	Waist circumference (measured in cm) will be assessed for change over time.	Assessed initially and every 6 months for up to 18 months