Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Southern California
About this trial
People with diabetes often experience foot ulcers, which can harm their ability to move, lower their quality of life, and increase the chances of losing a limb. These diabetic foot ulcers (DFUs) commonly come back (recur) even after they've healed, so it's crucial to stop them from returning to avoid toe, foot , or leg amputation. While wearing special shoes to reduce pressure on the feet is essential for healing and preventing DFUs, many people struggle to follow this treatment plan once their ulcers have healed. This study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 21 years
Healed diabetic foot ulcer within the past twelve months
Able to walk independently (use of a cane is acceptable)
Disqualifiers
Current active diabetic foot ulcer
History of amputation beside toe or part of the foot
Non-ambulatory at baseline
Self-reported deafness/blindness.
Trial design
Design model
Parallel
Treatments tested in this trial
Lifestyle-focused Occupational Therapy Intervention
BehavioralThe proposed intervention, led by trained occupational therapists, will focus on establishing sustainable self-care routines. It will consist of approximately 12 biweekly sessions, each lasting about an hour on average. Therapists will customize session timing and duration based on participant needs.
Education
Other interventionParticipants in the education group will receive standardized education materials on diabetic foot ulcers (DFUs), foot care, and offloading treatment to prevent foot ulcer recurrence.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Lifestyle-focused Occupational Therapy (OT) InterventionExperimental treatment 1 intervention
Group B: EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numbers of participants who have completed the study
Investigators will measure participant attendance, completion of planned/scheduled sessions, retention of participants in the intervention and education (control) groups.
Time frame
6-monthSecondary outcomes
1
Numbers of participants with diabetic foot ulcer recurrence
Rates of foot ulcer recurrence and any amputation.
Time frame
6-month2
Numbers of participants who report satisfaction with the program
Participants will complete the Short-form Patient Satisfaction Questionnaire (PSQ-18). The 18 items' scale ranges from 1 (strong agree) to 5 (strongly disagree). Selected participants will be invited to participate in semi-structured interviews.
Time frame
6-month3
Number of participants with diabetes distress
Participants will complete the Diabetes Distress Scale (DDS), a 17-item self-report instrument. Each item is rated on a 6-point scale from 1 (not a problem) to 6 (a very significant problem.
Time frame
6-month4
Participant's Quality of Life
Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) that evaluate physical, mental, and social health.
Time frame
6-monthSponsors and contacts
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Source ClinicalTrials.gov