NCT07268482

Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes

Randomised Control Study of Using a Pressure Monitoring Technology for Improving the Targeted Application, Monitoring, and Maintenance of Compression Therapy in Patients With Venous Leg Ulcers

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Feeltect Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators are conducting a study to find out if a new system can help improve the care of people with venous leg ulcers (VLU). Venous leg ulcers are wounds on the lower leg that need compression bandages to help them heal. In this study, patients will be randomly placed into one of two groups: * Group 1: Will receive the usual care for VLUs. * Group 2: Will use a new connected health system, called Tight Alright, along with their usual care. The Tight Alright system includes a small, wearable device that sits under a patient's bandage. This device measures the pressure at three points on the patient's lower leg and sends the information wirelessly to a mobile app. The app shows real-time pressure readings and also sends the data to a secure cloud database. This allows the patient's healthcare team to monitor their bandage pressure remotely and make sure it is just right. The aim is to help nurses and doctors apply the correct pressure every time, which is important for healing. The system can also alert the patient's healthcare team if the pressure drops, so they can decide if a patient's bandage needs adjusting, even when the patient is at home. The investigators will follow all participants for 90 days and then compare how well the ulcers have healed in both groups. This will help us find out if the new system can improve healing and make treatment safer and more effective.

Detailed description

This proposed study is a prospective, randomized, controlled trial designed to evaluate the effectiveness of a pressure-sensing compression therapy device for VLUs. Eligible patients will be identified through a combination of ankle brachial index measurements, venous duplex ultrasound, comprehensive wound assessment, and a review of their care plans. Informal carers, such as family members or friends, may participate to assist with device use and data transmission. All participants will receive detailed study information and provide written informed consent prior to enrolment. After enrolment, each patient will enter a two-week run-in period during which they will receive standard care. During this time, their wound will be photographed and measured using eKare wound monitoring technology. Patients whose wounds decrease in size by more than 40% during this period will be excluded to maintain a homogeneous study population. All participants will receive thorough training on device usage and data transmission, with their proficiency evaluated prior to the start of the study. Those who meet the inclusion criteria will then be randomly assigned to either the control or treatment group according to a computer-generated allocation schedule. The control group will receive standard care and use the pressure-sensing device with a blinded application (no feedback provided), with data transmitted for monitoring. The treatment group will also receive the same standard care, with the same type of compression bandages, when possible, but use the device with real-time feedback, enabling nurses to apply the targeted pressure reliably, and patients and carers to monitor pressure trends and apply additional compression as needed. Throughout 90 days all patients will continue with scheduled wound care, and at each visit, compression pressures and wound area will be assessed. Patients will take the device home, transmit daily pressure readings, and be instructed to apply additional compression if pressures fall below target thresholds. Study nurses will monitor data remotely and provide follow-up as needed. A quality-of-life questionnaire will also be given to the patients to fill in every two weeks. Patients will exit the study after 90 days, upon wound healing, or if complications arise. A final clinic evaluation and discharge questionnaire will be completed to assess patient experience and technology usability.

Conditions

• Venous Leg Ulcer (VLU)

Interventions

Type	Name	Description
DEVICE	A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy	The study will be conducted at merlin Park University Hospital Galway 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

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-09-30
• Completion: 2026-10-30
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: Ireland