Lifestyle Intervention for Diabetic Foot Ulcers

Overseen By Jason Garcia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Deafness, Blindness, Amputation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 3 to 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a lifestyle-based treatment to help people better manage diabetic foot ulcers. Led by an occupational therapist, it focuses on how changes in daily habits can improve foot care. The trial aims to determine if this approach is easy to follow and truly effective. It suits those with diabetic foot ulcers needing special support when walking. Participants must be able to join online sessions and walk independently, even with a walking aid. As an unphased trial, this study offers a unique opportunity for patients to explore innovative lifestyle changes that could significantly enhance their foot care routine.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this lifestyle-based intervention is safe for diabetic foot ulcer management?

Research has shown that lifestyle changes for treating diabetic foot ulcers are generally safe. In one study, a 12-week exercise program for these ulcers proved safe when doctors, nurses, and patients helped design it. This suggests that similar lifestyle changes, like those in the current trial, are likely safe as well. Participants in these studies have not reported major side effects, indicating that the treatment usually does not cause harm. This information should reassure potential participants about the safety of joining this lifestyle-focused trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this lifestyle-based intervention for diabetic foot ulcers because it offers a unique approach compared to traditional treatments like wound dressings, antibiotics, and surgical options. This method utilizes telemedicine to deliver personalized sessions with a licensed occupational therapist, which could improve accessibility and convenience for patients. By focusing on lifestyle changes, the intervention aims to empower patients with tools and strategies to manage their condition actively, potentially improving healing outcomes and reducing recurrence rates in a way that existing treatments may not address.

What evidence suggests that this lifestyle-based intervention is effective for diabetic foot ulcers?

Research has shown that changing daily habits can help treat diabetic foot ulcers. In one study, participants in self-care and family support programs for three months improved their habits, aiding ulcer healing. Another study found that lifestyle changes made it easier for patients to regularly use special devices that relieve foot pressure, crucial for healing. Educational programs have also successfully helped patients change their lifestyles, aiding in managing and preventing foot ulcers. These findings suggest that focusing on lifestyle changes can be an important part of treating diabetic foot ulcers. Participants in this trial will receive a lifestyle-based intervention delivered by an occupational therapist through telemedicine, aiming to incorporate these beneficial lifestyle changes. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 21 who speak English or Spanish and have an active diabetic foot ulcer (DFU) that requires offloading, which means reducing pressure on the foot to help healing.

Inclusion Criteria

I have had a diabetic foot ulcer that required special footwear or a cast.

I am 21 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lifestyle-based treatment sessions virtually with a licensed occupational therapist

3 to 8 weeks

Up to 8 sessions (virtual)

Follow-up

Participants are monitored for DFU-related outcomes including healing, amputation, and ulcer recurrence

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle-based intervention

Trial Overview The study tests a new way to manage DFUs with a lifestyle-based intervention led by an occupational therapist. It's designed to see if this personalized approach helps patients better care for their ulcers.

How Is the Trial Designed?

Group I: Lifestyle-based intervention by an occupational therapist Experimental Treatment 1 Intervention

Participants with diabetic foot ulcers will be offered lifestyle-based treatment sessions over telemedicine for up to 8 sessions with a licensed occupational therapist.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8826777/

Investigating the effect of educational intervention based ... The results of this study can be used in educational interventions aiming at patients with diabetic foot ulcers to change their lifestyle and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03909802

Effect of Self- and Family Management of Diabetic Foot ... The study participants who joined completely the self- and family management of diabetic foot ulcer programs during three months would have a better behavior, ...

3. withpower.com withpower.com/trial/phase-foot-ulcer-8-2024-7f4fa

Lifestyle Intervention for Diabetic Foot Ulcers 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 ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dme.14326

Effectiveness of psychosocial interventions for the ... Most psychosocial intervention randomized controlled trials assessing foot ulcer outcomes in people with diabetes were prevention studies.

5. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-025-01822-5

“New technologies applied in self-care to patients with ... This study demonstrated that early detection of temperature deviations resulted in a reduction of up to 70% in ulcer recurrence rates, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06487780

Evaluating a Lifestyle Intervention to Prevent Recurrence of ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8129742/

The effectiveness of home-based nursing intervention in ... The aim of this study is to provide an overview on the effectiveness of home-based nursing intervention in the elderly patients with reoccurring diabetic foot ...

8. bmcendocrdisord.biomedcentral.com bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-020-00637-x

Effect of a telemedicine intervention for diabetes-related foot ... The aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/dmrr.2701

Prevention of foot ulcers in the at‐risk patient with diabetes ... The aim of this systematic review is to investigate the effectiveness of interventions to prevent first and recurrent foot ulcers in persons with diabetes