Clinical Trial

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

Study acronym: ACHIEVE
Not Yet Recruiting
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Summary
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
Trial Details
NCT Number NCT07152717
Lead Sponsor Feeltect Limited
Collaborators: Parkview Health
Conditions Venous Leg Ulcers (VLUs)
Enrollment 40 participants
Start Date 2025-10-01
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-03