Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
ID06278935

Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers

Led by University of Southern California · Updated on 2025-05-18

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Diabetic foot ulcers (DFUs) are common and can lead to serious complications like major amputation and death. This research aims to develop and test a lifestyle-focused intervention led by occupational therapists to help patients better manage their DFU care. The study primarily seeks to determine if this tailored approach is acceptable and feasible for patients who need offloading treatment as part of comprehensive DFU management. Participants with DFUs requiring offloading treatment will receive up to eight virtual lifestyle-based self-management sessions with a licensed occupational therapist over about eight weeks. This intervention will be co-developed with input from patients, caregivers, family members, and the DFU care team. At the end of the intervention, focus group interviews will be conducted with care team members and therapists to gather feedback on acceptability and feasibility. During the study, participants will complete surveys before and after the intervention to measure patient satisfaction, diabetes distress, and knowledge about offloading. Some will also participate in interviews to discuss their experiences with the intervention. Researchers will monitor DFU-related outcomes for six months after enrollment. Participation involves telemedicine sessions and follow-up assessments, with total intervention lasting approximately eight weeks.

CONDITIONS

Brief Title

Adapting Lifestyle Offloading for DFUs

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • English speaking
  • Age 21 years or older
  • History of active diabetic foot ulcer necessitating offloading
  • Capacity to provide informed consent
  • Access to telehealth (internet connection and equipment)
  • Ability to walk independently or with an assistive device
  • Self-reported life expectancy of more than one year
Not Eligible

You will not qualify if you...

  • Self-reported deafness or blindness
  • History of lower extremity amputation besides toes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (virtual)

Outpatient Treatment

Duration - Up to 8 weeks

Participants receive lifestyle-based treatment sessions virtually with a licensed occupational therapist to help manage diabetic foot ulcers.

Up to 8 virtual treatment sessions

Follow-up

Duration - 6 months

Participants are monitored for diabetic foot ulcer-related outcomes after completing the intervention.

Follow-up assessments post-enrollment

Trial Site Locations

Total: 1 location

1

University of Southern California

Los Angeles, California, United States, 90033

Actively Recruiting

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Research Team

T

Tze Woei Tan

J

Jason Garcia

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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