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

Feeltect Limited

Status: Not yet enrolling

Conditions: Venous Leg Ulcers (VLUs)

Treatments: Device: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07152717

NUR25-0409WoundCompress

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Control Cohort

Other group

Description:

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.

Treatment:

Device: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy

Intervention Cohort

Experimental group

Description:

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.

Treatment:

Device: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy