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

Primary Purpose

Diabetic Foot Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapist-Directed Re-loading
Sponsored by
Mercer University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Foot Ulcer focused on measuring Diabetes, re-loading, ulcer recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Piedmont HealthcareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapist-Directed Re-loading

Self-Directed Re-loading

Arm 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).

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

Outcomes

Primary Outcome Measures

Incidence of Ulcer Recurrence
Assessment of incidence of any plantarr ulcer recurrence.
Change in walking behavior (steps)
Actual assessment of change in walking behavior will be assessed by number of steps.
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).

Secondary Outcome Measures

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.
Bio-thesiometer
Assesses vibration sense
Body Mass Index (BMI) and disease risk
Weight and height will be combined to report BMI in kg/m^2.
Waist circumference
Waist circumference (measured in cm) will be assessed for change over time.

Full Information

First Posted
February 19, 2020
Last Updated
October 15, 2021
Sponsor
Mercer University
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1. Study Identification

Unique Protocol Identification Number
NCT04310137
Brief Title
Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence
Official Title
The Effect of Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercer University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetes, re-loading, ulcer recurrence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be unaware of in which group the participant was randomized.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapist-Directed Re-loading
Arm Type
Experimental
Arm 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).
Arm Title
Self-Directed Re-loading
Arm Type
No Intervention
Arm Description
Participants in this arm will be instructed to slowly increase their walking.
Intervention Type
Behavioral
Intervention Name(s)
Therapist-Directed Re-loading
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Ulcer Recurrence
Description
Assessment of incidence of any plantarr ulcer recurrence.
Time Frame
Over up to 18 months of follow-up.
Title
Change in walking behavior (steps)
Description
Actual assessment of change in walking behavior will be assessed by number of steps.
Time Frame
Assessed initially and every 6 months for 1 week for up to 18 months.
Title
Change in walking behavior (step timing)
Description
Actual assessment of change in walking behavior will be assessed by the timing of steps (how many steps in a given timeframe).
Time Frame
Assessed initially and every 6 months for 1 week for up to 18 months.
Secondary Outcome Measure Information:
Title
Exercise component of Summary of Diabetes Self-Care Activities Scale
Description
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.
Time Frame
Assessed initially and every 6 months for up to 18 months
Title
Bio-thesiometer
Description
Assesses vibration sense
Time Frame
Assessed initially and every 6 months for up to 18 months
Title
Body Mass Index (BMI) and disease risk
Description
Weight and height will be combined to report BMI in kg/m^2.
Time Frame
Assessed initially and every 6 months for up to 18 months
Title
Waist circumference
Description
Waist circumference (measured in cm) will be assessed for change over time.
Time Frame
Assessed initially and every 6 months for up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah M. Wendland, PhD
Phone
6785476775
Email
wendland_dm@mercer.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Teri Biven, DPT
Phone
404.605.2743
Email
teri.biven@piedmont.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah M. Wendland
Organizational Affiliation
Mercer University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piedmont Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teri Biven, DPT
Phone
404-605-2743
Email
Teri.Biven@piedmont.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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