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临床试验/NCT06439667
NCT06439667Enrolling By Invitation不适用

Virtually Supervised Tele-Exercise Platform for Accelerating Plantar Wound Healing

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
15
试验地点
1
主要终点
Tissue Oxygen Saturation (SatO2)

研究概览

简要总结

The purpose of the study is design and use a telemedicine platform which integrates video-chat, pre-programmed interactive game-based foot, and ankle exercise modules, and real-time quantitative performance metrics displayed to the clinician to improve patient's perfusion to the lower extremity, improve diabetic wound healing and prevent muscle loss in the lower extremity.This is a cross sectional and comparative feasibility study. It is designed to explore acceptability, feasibility and proof of concept/ .

详细描述

Foot ulceration is the most common and costly late complication of diabetes, with morbidity and mortality being worse than many cancers. It is estimated that up to one-third of people with diabetes will develop a diabetic foot ulcer (DFU) in their lifetime. Non-healing DFUs are a leading cause of hospitalization, amputation, disability, and death among people with diabetes. In the United States, one-third of all diabetes-related costs are spent on diabetic foot care, with two-thirds of the costs incurred in inpatient settings, constituting a substantial economic burden to society. Therefore, every means possible should be used to try to heal DFU and prevent amputation. In this regard, there is a significant body of evidence related to the clinical benefits of exercise for people with DFU, including improving blood flow and oxygen supply, muscle loss prevention, and joint mobility. Despite this evidence, exercise is not part of the standard care for wound healing, mainly because there is no solution for promoting and managing home-based exercise programs for people with DFU.

To address the gaps described above, the investigators propose an interactive foot and ankle tele-exercise platform called "Tele-FootX". This platform allows clinicians to remotely and virtually supervise exercise tasks and coach patients to perform evidence-based foot and ankle exercises inspired by the validated Buerger-Allen (BA), while also educating and monitoring the patients adherence to the exercise program.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Male or female adults (age 18 years and older)
  • Having Diabetic foot ulcer
  • Ambulatory (in the home without the aid of another person)
  • Willing and able to provide informed consent

排除标准

  • Foot wound present for more than a year
  • HbA1c > 12%
  • ABI index limb is <0.60 and/or they are being considered for revascularization within the course of the study
  • Ulcer involving bone or tendon
  • Ulcer not caused by diabetes
  • Fully confined to a wheelchair
  • Any condition limiting the ability to engage in Tele-FootX exercise routine such as major cognitive decline, and major visual or hearing problem
  • Unable or unwilling to attend prescribed clinic visits

结局指标

主要结局

Tissue Oxygen Saturation (SatO2)

时间窗: baseline, 15 minutes

For measuring tissue oxygen saturation (SatO₂), we will use a validated, non-invasive near-infrared (NIR) imaging device (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Canada). The device estimates SatO₂ levels in superficial tissue by tracing the wound perimeter in real-time. To minimize bias related to wound size and SatO₂ measurement, all wounds will be traced along their internal borders-excluding surrounding skin-using a standardized technique across all participants. Measurements will be conducted at baseline and at the end of the Tele-FootX session, which is expected to last approximately 15 minutes.

次要结局

  • Muscle Activation(15 minutes)
  • Percentage of successfully completed leg exercise tasks within a 10-Minute session(10 minutes)

研究者

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

Bijan Najafi, PhD

Professor of Surgery

University of California, Los Angeles

研究点 (1)

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