Clinical Trial

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

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07268482
Lead Sponsor Feeltect Limited
Collaborators: University of Galway, CORRIB-CURAM Vascular Group, University of Galway, Galway, Ireland
Conditions Venous Leg Ulcer (VLU)
Enrollment 40 participants
Start Date 2026-01-15
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-05