MedDataX Logo

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

NCT ID: NCT04310137

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor will be unaware of in which group the participant was randomized.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Therapist-Directed Re-loading

Intervention Type BEHAVIORAL

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.

Self-Directed Re-loading

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mercer University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Deborah M. Wendland, Ph.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deborah M. Wendland

Role: PRINCIPAL_INVESTIGATOR

Mercer University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Piedmont Healthcare

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Deborah M. Wendland, PhD

Role: CONTACT

[email protected]
6785476775

Teri Biven, DPT

Role: CONTACT

[email protected]
404.605.2743

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Teri Biven, DPT

Role: primary

[email protected]
404-605-2743

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H1908191

Identifier Type: -

Identifier Source: org_study_id