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

RecruitingNAAges 18 Years - anyAllFeeltect Limited
NCT07152717 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * \<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
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What it tests

  • A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
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Where

1 site
Parkview Center for Wound Healing
Fort Wayne, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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