Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes (NCT07268482) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes
Ireland40 participantsStarted 2026-01-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* Osteomyelitis, cellulitis or gangrene in study limb
* Subjects with an amputation above transmetatarsal in study limb
* Active malignancy affecting study limb
* Index ulcer is of arterial aetiology (ABPI \<0.8)
* Pregnant or breast-feeding women or women of childbearing potential not willing to use a method of highly effective contraception for the duration of the study
* Planned vascular surgery, angioplasty or thrombolysis procedures during study period. Or patients who are within six weeks of having had such a procedure
* Planned surgical procedure during study period for the index wound
* Prior skin replacement, negative-pressure therapy and ultrasound therapy to the study wound in the two weeks before screening
* Currently receiving or has received radio or chemotherapy within three months of randomisation
* Index wound would require ultrasound near an electronic implant or prosthesis
* Not capable of providing informed consent
* C…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage area reduction per day
Timeframe: From enrollment to the end of treatment 9 months