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

Not Applicable

Not yet recruiting

• Conditions: Venous Leg Ulcers (VLUs)

• Registration Number: NCT07152717
• Lead Sponsor: Feeltect Limited

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Study Start: 2025-10-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage area reduction per day	From enrollment to the end of treatment at 5 weeks	The daily rate of wound area reduction represented as a percentage, calculated by comparing the wound size at the end of the treatment (Aend) with the wound size at the start of treatment (Astart) and normalising for the length of time for treatment (T). (Aend - Astart)/Astart\*100/T

Secondary Outcome Measures

Name	Time	Method
Average pressure	From enrollment to the end of treatment at 5 weeks	The average pressure applied over the duration of treatment
Percentage of patients healed	From enrollment to the end of treatment at 5 weeks	The percentage of patients healed completely within the study period

Trial Locations

Locations (1)

Parkview Center for Wound Healing; 🇺🇸 Fort Wayne, Indiana, United States