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

NIH RePORTER · NIH · R03 · $124,500 · view on reporter.nih.gov ↗

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
UNIVERSITY OF SOUTHERN CALIFORNIA
Principal Investigator
Tze-Woei Tan
Activity code
R03
Funding institute
NIH
Fiscal year
2024
Award amount
$124,500
Award type
1
Project period
2024-07-01 → 2026-06-30