Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment

Официальное название

Assessment of a Connected-health, Pressure Monitoring Technology for Improving Clinical Outcomes of Compression Therapy in the Treatment of Venous Leg Ulcers

Обзор

This study evaluates the effectiveness of a connected-health, pressure monitoring technology (Tight Alright) to improve clinical outcomes of compression therapy in patients with venous leg ulcers (VLUs). Compression therapy is the standard of care for VLUs, but achieving and maintaining therapeutic sub-bandage pressure is challenging due to patient variability and lack of objective feedback. The Tight Alright system includes a wearable device that measures sub-bandage pressure at multiple points on the leg and transmits data to a mobile app and cloud database, enabling both guided compression application at the point-of-care and guided compression maintenance via remote monitoring. The study will be conducted at Parkview Noble Center for Wound Healing and will include two cohorts: a control group receiving standard unguided compression therapy with blinded device use (i.e. compression pressures will be blinded at the point of care but monitored remotely), and an intervention group using Tight Alright technology to guide compression application and reapplication. Outcomes will include wound healing rates, time to healing, pressure maintenance, patient adherence, and usability. The study aims to determine whether integrating connected-health pressure monitoring can improve consistency of compression therapy, accelerate healing, and enhance patient engagement in the treatment of venous leg ulcers

Вмешательства

• Устройство A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
  The Tight Alright system, developed by FeelTect Limited, consists of a wearable, pressure sensing device that measures sub-bandage pressure at three regions along the length of the lower leg. The wearable device transmits data wirelessly to a mobile app on a smart device, which then displays the data in real-time. The mobile app is also capable of transmitting data to a remote cloud database, via the internet, where it can be viewed on a remote dashboard (i.e., via a secure webpage).

Первичные конечные точки

• Percentage area reduction per day [Срок оценки: From enrollment to the end of treatment at 5 weeks]

Вторичные конечные точки (2)

• Average pressure [Срок оценки: From enrollment to the end of treatment at 5 weeks]
• Percentage of patients healed [Срок оценки: From enrollment to the end of treatment at 5 weeks]

Критерии участия

Критерии включения

• Patient of Parkview Noble Center for Wound Healing
• Adults 18+ with venous leg ulcers receiving compression therapy treatment prescribed by outpatient wound clinic.
• Capable of using use a smart device
• Owns a smart phone or device capable of downloading the Mobile App

Критерии исключения

• <18 years old
• Unable to consent in English
• Cellulitis in affected limb
• Acute deep vein thrombosis in affected limb
• Active malignancy in affected limb
• Prisoners
• Currently enrolled in or has been enrolled in another investigation device or drug trial in the last 30 days

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Parkview Center for Wound Healing — Fort Wayne

Идентификаторы

NCT: NCT07152717 · NUR25-0409WoundCompress

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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