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

NCT04310137 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-10-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Mercer University

    lead OTHER

Principal Investigators

  • Deborah M. Wendland · Mercer University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04310137 on ClinicalTrials.gov