# Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study

> **NIH NIH R03** · UNIVERSITY OF SOUTHERN CALIFORNIA · 2024 · $124,500

## Abstract

ABSTRACT
In the United States, millions of individuals with diabetes suffer from diabetic foot ulcers (DFUs) that negatively
impact physical function, reduce quality of life, increase the risk of amputation, and drive up healthcare utilization
and costs. These ulcers frequently recur after healing, making it imperative to prevent their recurrence to avoid
adverse limb outcomes, major amputation, and death. Although offloading foot pressure is vital for DFU healing
and prevention, many patients find it difficult to adhere to offloading treatment recommendations following
healing. This study aims to evaluate the feasibility of a lifestyle-focused occupational therapy (OT) intervention
to help patients develop self-care routines and habits that support consistent offloading and foot care. The pilot
randomized controlled trial will enroll 60 participants with healed DFUs and randomly assign them to either the
OT intervention group or a control group. This mixed-methods study has three aims over two years. Aim 1 is to
determine if the OT intervention is feasible for patients at risk of DFU recurrence; Aim 2 is to assess patient and
provider satisfaction with the OT intervention and the role that occupational therapists play in diabetic limb care
using surveys, interviews, and focus groups; and Aim 3 is to compare DFU recurrence rates and changes in
diabetes distress and quality of life between the two groups in pre- and post-evaluation. The lifestyle-focused
OT intervention is expected to be feasible and acceptable to patients and providers in DFU prevention. It may
improve adherence to offloading treatment and patient-reported outcomes. This study will provide preliminary
data on this patient-centered approach to prevent DFU recurrence and improve care for this high-risk population.
The results of this feasibility study will support an R01 submission that will rigorously evaluate the cost-
effectiveness of the OT intervention through a large randomized clinical trial. The ultimate goal of this R03
proposal is to enhance the ability of the PI (Dr. Tan) to transition to an independent investigator by providing pilot
data to help support a subsequent R01 proposal.

## Key facts

- **NIH application ID:** 10952328
- **Project number:** 1R03DK140420-01
- **Recipient organization:** UNIVERSITY OF SOUTHERN CALIFORNIA
- **Principal Investigator:** Tze-Woei Tan
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $124,500
- **Award type:** 1
- **Project period:** 2024-07-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10952328

## Citation

> US National Institutes of Health, RePORTER application 10952328, Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study (1R03DK140420-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10952328. Licensed CC0.

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