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Набор по приглашению NCT06439667

Tele-Exercise Platform for Plantar Wound Healing

— Наблюдательное Diabetic Foot Ulcer Wound Healing Wound Care

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Diabetic Foot Ulcer, Wound Healing, Wound Care. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Virtually Supervised Tele-Exercise Platform for Accelerating Plantar Wound Healing

Обзор

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/ .

Подробное описание

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.

Первичные конечные точки

  • Tissue Oxygen Saturation (SatO2) [Срок оценки: baseline, 15 minutes]
Вторичные конечные точки (2)
  • Muscle Activation [Срок оценки: 15 minutes]
  • Percentage of successfully completed leg exercise tasks within a 10-Minute session [Срок оценки: 10 minutes]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 1 центр
  • University California, Los Angeles — Los Angeles

Публикации

  • Finco MG, Najafi B, Zhou H, Hamad A, Ibrahim R, Al-Ali F. Game-based intradialytic non-weight-bearing exercise training on gait speed and balance in older adults with diabetes: a single-blind randomized controlled trial. Sci Rep. 2023 Aug 30;13(1):14225. doi: 10.1038/s41598-023-41290-3. PMID 37648695
  • Lee M, Hamad A, Azarian M, Beom J, Ouattas A, Dehghan Rouzi M, Rodriguez N, Quach N, Ibrahim R, Mathew M, Talal T, Al-Ali F, Najafi B. Efficacy and Feasibility of Intradialytic Plantar Electrical Stimulation in Patients With Diabetes: A Randomized Double-Blind Controlled Trial. Diabetes Care. 2024 Dec 1;47(12):2205-2213. doi: 10.2337/dc24-0928. PMID 39316389

Идентификаторы

NCT: NCT06439667 · IRB-24-6284 · 1R43AG082614-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗