Not Yet RecruitingNot Applicable

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

United States40 participantsStarted 2025-10-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage area reduction per day

Timeframe: From enrollment to the end of treatment at 5 weeks

Trial details

NCT IDNCT07152717

SponsorFeeltect Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Brooke Randol, MSN, RN, AGCNS-BC, CMSRN, CWS

(260) 347-8610 Brooke.randol@parkview.com

View on ClinicalTrials.gov More Venous Leg Ulcers (VLUs) trials