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Behavioral Intervention

Lifestyle Intervention for Diabetic Foot Ulcers

N/A

Waitlist Available

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 21 years

Be older than 18 years old

Must not have

Current active diabetic foot ulcer

History of amputation beside toe or part of the foot

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a program focused on lifestyle changes can help people with diabetes prevent foot ulcers from coming back. Diabetic foot ulcers can cause serious problems, including the risk of losing

Who is the study for?

This trial is for individuals with diabetes who have previously had foot ulcers. Participants should be interested in learning how to prevent future ulcers through lifestyle changes and are willing to follow a treatment plan that includes using special shoes designed to reduce foot pressure.

What is being tested?

The study tests if a program focused on daily routines and habits can help people consistently use therapeutic footwear and manage their diabetes better, aiming to prevent the recurrence of diabetic foot ulcers.

What are the potential side effects?

Since this trial involves education and lifestyle interventions rather than medication, side effects may include discomfort from wearing special shoes or challenges adapting new habits but no medical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active foot ulcer due to diabetes.

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I have had an amputation other than a toe or part of the foot.

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I cannot walk by myself.

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I am deaf or blind.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Numbers of participants who have completed the study

Secondary study objectives

Number of participants with diabetes distress

Numbers of participants who report satisfaction with the program

Numbers of participants with diabetic foot ulcer recurrence

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lifestyle-focused Occupational Therapy (OT) InterventionExperimental Treatment1 Intervention

Participants in the intervention group will engage in telemedicine sessions led by trained occupational therapists.

Group II: EducationActive Control1 Intervention

Participants in the control group will receive standard education on foot self-care and offloading treatment aimed at preventing foot ulcer recurrence.

0 / 5Eligibility criteria met