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Идёт набор NCT04460573

Smart Boot Use to Measure Offloading Adherence

Фаза II С лечением Diabetic Foot Ulcer

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
В протоколе указаны: Offloading Boot.
Кому может быть актуально
Состояния в реестре: Diabetic Foot Ulcer. 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

Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading

Обзор

The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed. The investigators will look at three groups of participants: the first group will use removable offloading with reinforced education emphasizing continuous wear, including during rest and sleep, and not to remove it at any time. The second group will use removable offloading consistent with standard of care and receive education on recommended wear during walking or standing, with permission to remove the device during rest and sleep. The third group will use a smart removable offloading device that provides real-time adherence feedback via a smartwatch and smartphone, with additional personalized education informed by remotely monitored adherence data. The investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.

Вмешательства

  • Устройство Offloading Boot
    Removable offloading boot in one of three configurations provided to participants

Первичные конечные точки

  • Wound healing at 12 weeks or sooner [Срок оценки: Up to 12 weeks]
  • Time to wound healing [Срок оценки: Up to 12 weeks]
Вторичные конечные точки (4)
  • Patient acceptability [Срок оценки: Week 12]
  • Participant dropout rate [Срок оценки: From baseline through Week 12]
  • Adherence to offloading [Срок оценки: From baseline through Week 12 (summarized weekly)]
  • Percentage of Wound Area Reduction [Срок оценки: Percent reduction in wound area per week]

Критерии участия

Критерии включения

  • Male or female
  • ≥18 years old
  • Non-infected, non-ischemic DFU requiring offloading
  • Ambulatory at home with or without assistance
  • Willing and able to provide written informed consent

Критерии исключения

  • Wound present for > 1 year
  • HbA1c > 12%
  • ABI of index limb < 0.6 or non-detectable Doppler, and/or patient being considered for revascularization during the course of the study
  • Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wear the smart boot
  • Amputation proximal to the rearfoot on the affected extremity
  • Any clinically significant medical or psychiatric condition
  • Laboratory abnormality that would interfere with the ability to participate in the study
  • Concurrently participating in exercise training
  • Changes in psychotropic or sleep medication in the last 6 weeks
  • Ulcer involves bone
  • Ulcer not of diabetic origin
  • Unable or unwilling to attend prescribed clinic visits or comply with protocol

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 4 центра
  • Rancho Los Amigos National Rehabilitation Center — Downey
  • Verdugo Hills Hospital of USC — Glendale
  • Clemente Clinical Research — Los Angeles
  • Keck Medical Center of USC — Los Angeles

Идентификаторы

NCT: NCT04460573 · HS-20-00526

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗