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Therapist-Directed Re-loading for Foot Ulcer Recurrence

N/A
Waitlist Available
Led By Deborah M. Wendland
Research Sponsored by Mercer University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed initially and every 6 months for 1 week for up to 18 months.
Awards & highlights

Study Summary

This trial will see if giving specific instructions to people with diabetes on how to walk after an injury can prevent new foot ulcers.

Eligible Conditions
  • Diabetic Foot Ulcers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed initially and every 6 months for 1 week for up to 18 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed initially and every 6 months for 1 week for up to 18 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in walking behavior (step timing)
Change in walking behavior (steps)
Incidence of Ulcer Recurrence
Secondary outcome measures
Bio-thesiometer
Body Mass Index (BMI) and disease risk
Exercise component of Summary of Diabetes Self-Care Activities Scale
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Therapist-Directed Re-loadingExperimental Treatment1 Intervention
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 II: Self-Directed Re-loadingActive Control1 Intervention
Participants in this arm will be instructed to slowly increase their walking.

Find a Location

Who is running the clinical trial?

Mercer UniversityLead Sponsor
6 Previous Clinical Trials
1,030 Total Patients Enrolled
1 Trials studying Foot Ulcer
15 Patients Enrolled for Foot Ulcer
Deborah M. WendlandPrincipal InvestigatorMercer University
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Foot Ulcer
15 Patients Enrolled for Foot Ulcer

Media Library

Therapist-Directed Re-loading Clinical Trial Eligibility Overview. Trial Name: NCT04310137 — N/A
Foot Ulcer Research Study Groups: Therapist-Directed Re-loading, Self-Directed Re-loading
Foot Ulcer Clinical Trial 2023: Therapist-Directed Re-loading Highlights & Side Effects. Trial Name: NCT04310137 — N/A
Therapist-Directed Re-loading 2023 Treatment Timeline for Medical Study. Trial Name: NCT04310137 — N/A
~7 spots leftby Jun 2025
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