Diabetic Foot UlcerNCT06278935
Adapting Lifestyle Offloading for DFUs
A study testing Lifestyle-based intervention by an occupational therapist in people with Diabetic Foot Ulcer and Diabetic Foot, run by University of Southern California at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot
- What is being tested?
- Lifestyle-based intervention by an occupational therapist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to Apr 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
- English speaking
- Age 21 years or older
- History of active DFU 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
Who cannot join
- Self-reported deafness or blindness
- history of lower extremity amputation besides toes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90033
Tze-Woei Tan, 323-442-6835, tze-woei.tan@med.usc.edu
Stacey Schepens Niemiec, PhD, 323-442-2069, schepens@usc.edu
About this study
Official title: Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers
The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.
Read the detailed description
Diabetic foot ulcers (DFUs) frequently lead to major amputation and mortality. While relieving foot pressure (i.e., offloading) is vital for healing, many patients struggle to adhere to recommended offloading treatments. Participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. This occupational therapist-led lifestyle-focused intervention will be co-developed with participants, caregivers, family members, and DFU care team members.
Participants with DFUs will be offered lifestyle-based treatment sessions for up to 8 weeks (virtually) with a licensed occupational therapist. Participants will complete pre/post surveys and a subset will take part in an interview to clarify key findings from surveys and obtain patients' perspective of the effectiveness of the intervention. Investigators will also offer focus group interviews to the DFU care team members and occupational therapist to learn their perceptions on the intervention's acceptability, appropriateness, efficiency, and feasibility at the conclusion of the intervention.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot
- Being tested
- Lifestyle-based intervention by an occupational therapist
- Keywords
- Offloading diabetic foot ulcer, Lifestyle-focused intervention, Occupational therapy, Occupational therapist, Self management
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle-based intervention by an occupational therapistBehavioural
Participants with diabetic foot ulcers will be offered lifestyle-based treatment sessions virtually for up to 8 sessions (~8 weeks) with a licensed occupational therapist.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle-based intervention by an occupational therapist | Experimental | Participants with diabetic foot ulcers will be offered lifestyle-based treatment sessions over telemedicine for up to 8 sessions with a licensed occupational therapist. Receives: Behavioral: Lifestyle-based intervention by an occupational therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction (change from baseline)
Participants will fill out a general satisfaction survey, adapted from and comprising 18 items from a validated measure: Short-Form Patient Satisfaction Questionnaire (PSQ-18). The scale ranges from 1 (strongly agree) to 5 (strongly disagree).
Measured: Baseline and discharge from OT (3 to 8 weeks)
Secondary outcomes (3)
Diabetes distress (change from baseline)
Participants will complete the Type 2 Diabetes Distress Assessment System (T2D-DAS). The T2D-DAS is a validated, multidimensional self-report measure designed to assess diabetes-related distress in adults with type 2 diabetes. It includes 7 domain-specific sources of distress across key areas of diabetes self-management and psychosocial impact (i.e., 7 sources of distress including hypoglycemia, long-term health, health care provider, interpersonal issues, shame or stigma, health care access, and management demands). The T2D-DAS provides a comprehensive profile of diabetes distress. Each item is rated on a 5-point Likert scale ranging from 1 ("Not a problem") to 5 ("A very serious problem"). Subscale scores are calculated as the mean of items within each domain. Higher scores indicate greater diabetes distress.
Measured: Baseline and discharge from OT (3 to 8 weeks)
Offloading knowledge and attitudes (change from baseline)
Participants will complete 41 items of an offloading-specific knowledge and attitudes survey. This survey includes common factors known to influence healing of diabetic foot ulcers (e.g., history of ulcers, access to transportation) and assessment of a person's knowledge of good offloading practices and their attitudes toward those practices. Questions are mixed in style/format, including 5-point Likert (strongly disagree [1] to strongly agree [5]) items such as "My wound does not worry me because it is not painful", yes/no (e.g., "In the past I had a foot wound linked to my diabetes."), and short answer (e.g., "How do you get to the place where you receive treatment for your foot ulcer?"). There is no total score available. Change from baseline in the 27 Likert-scale questions will be assessed individually for each item.
Measured: Baseline and discharge from OT (3 to 8 weeks)
Frequency of DFU-related outcomes
Number of participants with various DFU-related outcomes including DFU healing, minor amputation, major amputation, and ulcer recurrence after healing as extracted from electronic medical record documentation 6 months post-enrollment to the intervention.
Measured: 6-month post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start10 Feb 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278935
- Sponsor's protocol ID
- APP-24-00887
- Status last verified
- May 2025
- First submitted
- 16 Feb 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schepens Niemiec SL, Styer L, Chapman J, Myong E, Moshtael R, Lopez C, Arteaga J, Wong E, Motta Morales D, Kumar N, Tan TW. Applying the ADAPT-ITT framework to adapt a lifestyle Redesign(R) occupational therapy intervention for diabetic foot ulcer self-management. Transl Behav Med. 2026 Jan 7;16(1):ibag030. doi: 10.1093/tbm/ibag030.
PubMed 42228560
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06278935
- Acronym / sponsor ID
- APP-24-00887
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot
- Keywords
- Offloading diabetic foot ulcer, Lifestyle-focused intervention, Occupational therapy, Occupational therapist, Self management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 26 Feb 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.
The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.
Detailed description
Diabetic foot ulcers (DFUs) frequently lead to major amputation and mortality. While relieving foot pressure (i.e., offloading) is vital for healing, many patients struggle to adhere to recommended offloading treatments. Participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. This occupational therapist-led lifestyle-focused intervention will be co-developed with participants, caregivers, family members, and DFU care team members.
Participants with DFUs will be offered lifestyle-based treatment sessions for up to 8 weeks (virtually) with a licensed occupational therapist. Participants will complete pre/post surveys and a subset will take part in an interview to clarify key findings from surveys and obtain patients' perspective of the effectiveness of the intervention. Investigators will also offer focus group interviews to the DFU care team members and occupational therapist to learn their perceptions on the intervention's acceptability, appropriateness, efficiency, and feasibility at the conclusion of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle-based intervention by an occupational therapist | Experimental | Behavioral: Lifestyle-based intervention by an occupational therapistParticipants with diabetic foot ulcers will be offered lifestyle-based treatment sessions over telemedicine for up to 8 sessions with a licensed occupational therapist. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking
- Age 21 years or older
- History of active DFU necessitating offloading
- Capacity to provide informed consent
- Access to telehealth (internet connection and equipment)
Key exclusion criteria (2 listed)
- Self-reported deafness or blindness
- history of lower extremity amputation besides toes
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-based intervention by an occupational therapistParticipants with diabetic foot ulcers will be offered lifestyle-based treatment sessions virtually for up to 8 sessions (~8 weeks) with a licensed occupational therapist. | Behavioural | Lifestyle-based intervention by an occupational therapist |
Primary outcome
Patient satisfaction (change from baseline)
Time frame: Baseline and discharge from OT (3 to 8 weeks)
Participants will fill out a general satisfaction survey, adapted from and comprising 18 items from a validated measure: Short-Form Patient Satisfaction Questionnaire (PSQ-18). The scale ranges from 1 (strongly agree) to 5 (strongly disagree).
3 secondary outcomes
Diabetes distress (change from baseline)
Time frame: Baseline and discharge from OT (3 to 8 weeks)
Offloading knowledge and attitudes (change from baseline)
Time frame: Baseline and discharge from OT (3 to 8 weeks)
Frequency of DFU-related outcomes
Time frame: 6-month post-enrollment
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 18 May 2025.
- Derived from this study: PubMed 42228560Schepens Niemiec SL, Styer L, Chapman J, Myong E, Moshtael R, Lopez C, Arteaga J, Wong E, Motta Morales D, Kumar N, Tan TW. Applying the ADAPT-ITT framework to adapt a lifestyle Redesign(R) occupational therapy intervention for diabetic foot ulcer self-management. Transl Behav Med. 2026 Jan 7;16(1):ibag030. doi: 10.1093/tbm/ibag030.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle-based intervention by an occupational therapist in people with Diabetic Foot Ulcer and Diabetic Foot, run by University of Southern California at 1 site 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 7 inclusion and 2 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 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (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?
Patient satisfaction (change from baseline) (time frame: Baseline and discharge from OT (3 to 8 weeks)). 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 NCT06278935, which also lists 1 linked publication.
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 18 May 2025.