About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
<18 years old
Unable to consent in English
Cellulitis in affected limb
Acute deep vein thrombosis in affected limb
Trial design
Treatments tested in this trial
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
Treatment groups
Sponsors and collaborators
Feeltect Limited
Lead sponsor
Parkview Health
Collaborator