← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed initially and every 6 months for 1 week for up to 18 months.

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.

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What end goal are researchers hoping to achieve by conducting this experiment?

"This clinical trial will evaluate changes in walking behavior, as well as Body Mass Index (BMI), waist circumference, and Bio-thesiometer readings over an 18 month period. Initial assessments will take place every 6 months for a duration of 1 week."

Answered by AI

What is the current capacity for enrollment in this trial?

"Affirmative. Clinicaltrials.gov contains evidence that this experiment is presently looking for volunteer patients, with an original posting date of May 1st 2021 and the most recent update being October 15th 2021. The study intends to recruit 30 people from a single centre."

Answered by AI

Are medical professionals currently seeking participants for this investigation?

"According to the official records on clinicaltrials.gov, this study is still open for enrolment. The initial posting date was May 1st 2021 and it has been updated as recently as October 15th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Deborah M. Wendland, Ph.D. 2021. "Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04310137.