An interventional study of Lifestyle-focused Occupational Therapy Intervention and Education in Diabetic Foot, Diabetic Foot Ulcer and Foot Ulcer, Diabetic, sponsored by University of Southern California. Recruiting at 3 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by University of Southern California · Not applicable, Interventional, and Prevention
Among 381 studies in Diabetic Foot with a site in United States — 67 open to participants now, 86 under way, 3 of them phase 3. Diabetic Foot · United States.
Among the 381 studies in Diabetic Foot with a site in United States, this one is the 161st largest by planned enrollment of the 322 interventional ones that give a count, is one of 30 that started in 2025, is one of 186 with no phase, reaches primary completion later than 25 of the 85 other live ones, and was the 322nd registered.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →67 of the 381 studies in Diabetic Foot with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →381 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 54 · Phase 3 37 · Phase 4 31
First in 1994; this study’s year is marked. 30 started in 2025.
Median enrollment 60 across the 322 interventional studies, 138 across the 58 observational. Of the 247 that completed or were terminated, 89 (36%) have results posted.
253 of 381 have an industry lead sponsor. The 10 most frequent:
University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
University of Southern California has 4 studies filed under Diabetic Foot — fewer than ten, so there is no comparison to draw.
33 of the studies in Diabetic Foot with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05369052Phase 3MicuRxSafety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI) | 2027-06-30 |
| NCT07852338Phase 3Applied Biologics, LLCa Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers | 2027-09 |
| NCT06420245Legacy Medical ConsultantsClinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management | 2026-11 |
| NCT06449638StimLabsModified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs | 2026-11 |
| NCT06681428Tides MedicalRising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | 2026-11-18 |
Among the 381 studies in Diabetic Foot with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in the intervention group will engage in telemedicine sessions led by trained occupational therapists.
Behavioral: Lifestyle-focused Occupational Therapy Intervention
Participants in the control group will receive standard education on foot self-care and offloading treatment aimed at preventing foot ulcer recurrence.
Other: Education
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.
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.
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-month
Numbers of participants with diabetic foot ulcer recurrence
Rates of foot ulcer recurrence and any amputation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6-month
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Commencing 24 months after the award initiation, all data will be deposited onto USC-provided OneDrive, with subsequent deposits occurring every six months thereafter.
Access criteria: Public
Started Jun 2025 (actual). Primary completion is estimated for Jun 2026, 11 months after the start.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 11 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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