跳至主要内容
临床试验/NCT06487780
NCT06487780招募中不适用

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

University of Southern California6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
6
主要终点
Numbers of participants who have completed the study

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >= 21 years
  • Healed diabetic foot ulcer within the past twelve months
  • Able to walk independently (use of a cane is acceptable)

排除标准

  • Current active diabetic foot ulcer
  • History of amputation beside toe or part of the foot
  • Non-ambulatory at baseline
  • Self-reported deafness/blindness.

结局指标

主要结局

Numbers of participants who have completed the study

时间窗: 6-month

Investigators will measure participant attendance, completion of planned/scheduled sessions, retention of participants in the intervention and education (control) groups.

次要结局

  • Numbers of participants with diabetic foot ulcer recurrence(6-month)
  • Number of participants with diabetes distress(6-month)
  • Numbers of participants who report satisfaction with the program(6-month)
  • Participant's Quality of Life(6-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tze-Woei Tan

Associate Professor of Clinical Surgery

University of Southern California

研究点 (6)

Loading locations...

相似试验