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

NCT04310137 | Unknown DMC

• 1 other identifier: H1908191
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes; re-loading; ulcer recurrence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Exercise component of Summary of Diabetes Self-Care Activities Scale

  Assessed initially and every 6 months for up to 18 months

• Bio-thesiometer

  Assessed initially and every 6 months for up to 18 months

• Body Mass Index (BMI) and disease risk

  Assessed initially and every 6 months for up to 18 months

• Waist circumference

  Assessed initially and every 6 months for up to 18 months

Study Arms (2)

Therapist-Directed Re-loading

EXPERIMENTAL

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

Self-Directed Re-loading

NO INTERVENTION

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

Interventions

Therapist-Directed Re-loading 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.

Therapist-Directed Re-loading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With or without peripheral neuropathy
• Able to safely exercise
• Have a recently closed plantar ulceration

You may not qualify if:

• Presence of an open plantar ulceration
• Presence of an untreated infection
• Presence of osteomyelitis or gangrene

Sponsors & Collaborators

• Mercer University: lead

Study Sites (1)

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Deborah M. Wendland

  Mercer University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah M. Wendland, PhD

CONTACT

6785476775; wendland_dm@mercer.edu

Teri Biven, DPT

CONTACT

404.605.2743; teri.biven@piedmont.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be unaware of in which group the participant was randomized.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: March 17, 2020
• Study Start: May 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available following the study conclusion and its dissemination (6 months after publication).
• Access Criteria: This information will be shared with researchers for meta-analyses through the data repository.

Locations

US (1)