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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFeeltect Limited

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

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Feeltect Limited

Lead sponsor

Parkview Health

Collaborator