Diabetic FootNCT06487780
Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers
A study testing Lifestyle-focused Occupational Therapy Intervention and Education in people with Diabetic Foot and Diabetic Foot Ulcer, run by University of Southern California at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Diabetic
- What is being tested?
- Lifestyle-focused Occupational Therapy Intervention and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jun 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 21 years
- Healed diabetic foot ulcer within the past twelve months
- Able to walk independently (use of a cane is acceptable)
Who cannot join
- Current active diabetic foot ulcer
- History of amputation beside toe or part of the foot
- Non-ambulatory at baseline
- Self-reported deafness/blindness.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Tze Woei Tan
- Recruiting
Keck Hospital of USC
Los Angeles, California, 90033
Tze-Woei Tan
Stacey Schepens Niemiec, PhD
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
Tze-Woei Tan
Stacey Schepens Niemiec
About this study
Official title: Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study
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.
Read the detailed description
Diabetic foot ulcers (DFUs) are a significant complication of diabetes, responsible for 80% of lower extremity amputations in the United States and posing a substantial burden on patients and society. Despite treatment, up to 23% of DFUs remain unhealed at 12 months, with recurrence rates of 40% within a year and 65% within three years. Proper offloading of foot pressure and glucose control is crucial for preventing recurrent DFUs, especially in cases of neuropathy. While standard clinical practice includes patient education and therapeutic footwear prescription, adherence to offloading treatment often falls short due to non-medical factors such as insufficient understanding and difficulties integrating offloading into daily routines. To tackle these challenges, we propose a lifestyle-focused intervention, conducted by trained occupational therapist (OT), aiming at fostering consistent self-care habits and routines.The objective of this pilot trial is to evaluate the feasibility acceptability of a lifestyle-focused OT intervention for enhancing offloading treatment in high-risk individuals with a history of healed DFUs.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Diabetic, Foot Wound
- Being tested
- Lifestyle-focused Occupational Therapy Intervention, Education
- Keywords
- Diabetic foot ulcer, lifestyle intervention
- Medical subject headings
- Diabetic Foot, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle-focused Occupational Therapy InterventionBehavioural
The 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.
EducationOther
Participants in the education group will receive standardized education materials on diabetic foot ulcers (DFUs), foot care, and offloading treatment to prevent foot ulcer recurrence.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle-focused Occupational Therapy (OT) Intervention | Experimental | Participants in the intervention group will engage in telemedicine sessions led by trained occupational therapists. Receives: Behavioral: Lifestyle-focused Occupational Therapy Intervention |
| Education | Active comparator | Participants in the control group will receive standard education on foot self-care and offloading treatment aimed at preventing foot ulcer recurrence. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-month
Secondary outcomes (4)
Numbers of participants with diabetic foot ulcer recurrence
Rates of foot ulcer recurrence and any amputation.
Measured: 6-month
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.
Measured: 6-month
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.
Measured: 6-month
Participant's Quality of Life
Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) that evaluate physical, mental, and social health.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start11 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups, with an equal number in each group.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tze-Woei Tan, University of Southern California
- Investigators
- Tze Woei Tan, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487780
- Sponsor's protocol ID
- APP-24-03267
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators intend to share de-identified demographic, clinical, and survey data, along with qualitative data from interviews. This data will be stored in USC-provided OneDrive accounts, approved for Confidential Data storage according to USC standards. All de-identified scientific data, including raw/measured and derived data, will be preserved and shared to support reproducibility and reusability. Research results will be published in peer-reviewed scientific journals and presented at selected scientific meetings. Manuscripts accepted by journals without free access will be publicly available on Pubmed Central, in accordance with NIH guidelines for Sharing of Research Data.
Publications
Pyatak EA, Carandang K, Rice Collins C, Carlson M. Optimizing Occupations, Habits, and Routines for Health and Well-Being With Lifestyle Redesign(R): A Synthesis and Scoping Review. Am J Occup Ther. 2022 Sep 1;76(5):7605205050. doi: 10.5014/ajot.2022.049269.
PubMed 36053733Pyatak EA, Carandang K, Vigen CLP, Blanchard J, Diaz J, Concha-Chavez A, Sequeira PA, Wood JR, Whittemore R, Spruijt-Metz D, Peters AL. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial. Diabetes Care. 2018 Apr;41(4):696-704. doi: 10.2337/dc17-1634. Epub 2018 Jan 19.
PubMed 29351961
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study
- ClinicalTrials.gov ID
- NCT06487780
- Acronym / sponsor ID
- APP-24-03267
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Diabetic, Foot Wound
- Keywords
- Diabetic foot ulcer, lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetic foot ulcers (DFUs) are a significant complication of diabetes, responsible for 80% of lower extremity amputations in the United States and posing a substantial burden on patients and society. Despite treatment, up to 23% of DFUs remain unhealed at 12 months, with recurrence rates of 40% within a year and 65% within three years. Proper offloading of foot pressure and glucose control is crucial for preventing recurrent DFUs, especially in cases of neuropathy. While standard clinical practice includes patient education and therapeutic footwear prescription, adherence to offloading treatment often falls short due to non-medical factors such as insufficient understanding and difficulties integrating offloading into daily routines. To tackle these challenges, we propose a lifestyle-focused intervention, conducted by trained occupational therapist (OT), aiming at fostering consistent self-care habits and routines.The objective of this pilot trial is to evaluate the feasibility acceptability of a lifestyle-focused OT intervention for enhancing offloading treatment in high-risk individuals with a history of healed DFUs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups, with an equal number in each group.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle-focused Occupational Therapy (OT) Intervention | Experimental | Behavioral: Lifestyle-focused Occupational Therapy InterventionParticipants in the intervention group will engage in telemedicine sessions led by trained occupational therapists. |
| Education | Active comparator | Other: EducationParticipants in the control group will receive standard education on foot self-care and offloading treatment aimed at preventing foot ulcer recurrence. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 21 years
- Healed diabetic foot ulcer within the past twelve months
- Able to walk independently (use of a cane is acceptable)
Key exclusion criteria (4 listed)
- Current active diabetic foot ulcer
- History of amputation beside toe or part of the foot
- Non-ambulatory at baseline
- Self-reported deafness/blindness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle-focused Occupational Therapy InterventionThe 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. | Behavioural | Lifestyle-focused Occupational Therapy (OT) Intervention |
| EducationParticipants in the education group will receive standardized education materials on diabetic foot ulcers (DFUs), foot care, and offloading treatment to prevent foot ulcer recurrence. | Other | Education |
Primary outcome
Numbers of participants who have completed the study
Time frame: 6-month
Investigators will measure participant attendance, completion of planned/scheduled sessions, retention of participants in the intervention and education (control) groups.
4 secondary outcomes
Numbers of participants with diabetic foot ulcer recurrence
Time frame: 6-month
Numbers of participants who report satisfaction with the program
Time frame: 6-month
Number of participants with diabetes distress
Time frame: 6-month
Participant's Quality of Life
Time frame: 6-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Results publication: PubMed 36053733Pyatak EA, Carandang K, Rice Collins C, Carlson M. Optimizing Occupations, Habits, and Routines for Health and Well-Being With Lifestyle Redesign(R): A Synthesis and Scoping Review. Am J Occup Ther. 2022 Sep 1;76(5):7605205050. doi: 10.5014/ajot.2022.049269.
- Results publication: PubMed 29351961Pyatak EA, Carandang K, Vigen CLP, Blanchard J, Diaz J, Concha-Chavez A, Sequeira PA, Wood JR, Whittemore R, Spruijt-Metz D, Peters AL. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial. Diabetes Care. 2018 Apr;41(4):696-704. doi: 10.2337/dc17-1634. Epub 2018 Jan 19.
- Individual participant dataSharing planned: Yes. The investigators intend to share de-identified demographic, clinical, and survey data, along with qualitative data from interviews. This data will be stored in USC-provided OneDrive accounts, approved for Confidential Data storage according to USC standards. All de-identified scientific data, including raw/measured and derived data, will be preserved and shared to support reproducibility and reusability. Research results will be published in peer-reviewed scientific journals and presented at selected scientific meetings. Manuscripts accepted by journals without free access will be publicly available on Pubmed Central, in accordance with NIH guidelines for Sharing of Research Data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tze Woei Tan principal investigator
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle-focused Occupational Therapy Intervention and Education in people with Diabetic Foot and Diabetic Foot Ulcer, run by University of Southern California at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tze-Woei Tan, MD (3234426835, tze-woei.tan@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of participants who have completed the study (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06487780, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.