Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment
NCT ID: NCT07152717
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-10-01
2026-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Cohort
Patients will receive their normal standard of care and usual pattern of wound care visits from the treating provider. The Tight Alright device will be placed under the compression wrap by a study investigator and data will be transmitted but blinded to clinicians and patients. All patients in the Control Cohort will complete the study prior to initiating patients into the Intervention Cohort.
A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
The Tight Alright system, developed by FeelTect Limited, consists of a wearable, pressure sensing device that measures sub-bandage pressure at three regions along the length of the lower leg. The wearable device transmits data wirelessly to a mobile app on a smart device, which then displays the data in real-time. The mobile app is also capable of transmitting data to a remote cloud database, via the internet, where it can be viewed on a remote dashboard (i.e., via a secure webpage).
Intervention Cohort
Patients will receive their normal standard of care with the addition of using the Tight Alright technology, applied by a study investigator, to guide the application of compression to targeted pressures. The Tight Alright technology will be used to monitor pressure in the home setting, using the app (point-of-care) and web-dashboard (remotely), and to guide the reapplication of targeted pressure. If pressures drop below 40 mmHg at the B sensor, for two consecutive readings, reapplications will be considered. Reapplication of compression using a top-up layer can be delivered in a number of different ways, including additional patient visits, patient, informal caregiver, self-management via teleconsultation, or independent self-management.
A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
The Tight Alright system, developed by FeelTect Limited, consists of a wearable, pressure sensing device that measures sub-bandage pressure at three regions along the length of the lower leg. The wearable device transmits data wirelessly to a mobile app on a smart device, which then displays the data in real-time. The mobile app is also capable of transmitting data to a remote cloud database, via the internet, where it can be viewed on a remote dashboard (i.e., via a secure webpage).
Interventions
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A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
The Tight Alright system, developed by FeelTect Limited, consists of a wearable, pressure sensing device that measures sub-bandage pressure at three regions along the length of the lower leg. The wearable device transmits data wirelessly to a mobile app on a smart device, which then displays the data in real-time. The mobile app is also capable of transmitting data to a remote cloud database, via the internet, where it can be viewed on a remote dashboard (i.e., via a secure webpage).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Parkview Health
OTHER
Feeltect Limited
INDUSTRY
Responsible Party
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Locations
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Parkview Center for Wound Healing
Fort Wayne, Indiana, United States
Countries
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Central Contacts
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Other Identifiers
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NUR25-0409WoundCompress
Identifier Type: -
Identifier Source: org_study_id
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