About this trial
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.
Eligibility criteria
Qualifiers
Adults with chronic venous leg ulcers (≥6-week and ≤5-year durations) currently in compression therapy treatment.
Between 5 and 100 cm2 wound area at randomization.
Ankle brachial pressure index (ABPI) of >0,8
Capable of using use a smart device.
Disqualifiers
Uncontrolled diabetes [haemoglobin A1c (HbA1c) ≥12% in the last 3 months]
Index ulcer has active infection on day of inclusion requiring systemic antibiotic therapy
Renal failure
Exposed tendon, ligament, muscle or bone in the index ulcer
Trial design
Treatments tested in this trial
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
Treatment groups
Sponsors and collaborators
Feeltect Limited
Lead sponsor
University of Galway
Collaborator
CORRIB-CURAM Vascular Group, University of Galway, Galway, Ireland
Collaborator