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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Behavioral: Therapist-Directed Re-loading

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah M. Wendland, PhD; Phone Number: 6785476775; Email: wendland_dm@mercer.edu
• Study Contact Backup: Name: Teri Biven, DPT; Phone Number: 404.605.2743; Email: Teri.Biven@piedmont.org

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont Healthcare
      • Contact: Teri Biven, DPT; Phone Number: 404-605-2743; Email: Teri.Biven@piedmont.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapist-Directed Re-loading; 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).	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.
No Intervention: Self-Directed Re-loading; Participants in this arm will be instructed to slowly increase their walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Ulcer Recurrence	Assessment of incidence of any plantarr ulcer recurrence.	Over up to 18 months of follow-up.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Bio-thesiometer	Assesses vibration sense	Assessed initially and every 6 months for up to 18 months
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
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

Collaborators and Investigators

• Sponsor: Mercer University
• Investigators: Principal Investigator: Deborah M. Wendland, Mercer University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes; re-loading; ulcer recurrence
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Disease Attributes; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Recurrence
• Other Study ID Numbers: H1908191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified step data will be made available through a repository upon conclusion of the study and its dissemination.
• IPD Sharing Time Frame: Data will be available following the study conclusion and its dissemination (6 months after publication).
• IPD Sharing Access Criteria: This information will be shared with researchers for meta-analyses through the data repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No