Venous Leg Ulcer (VLU)NCT07268482
Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes
A study testing A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy in people with Venous Leg Ulcer (VLU), run by Feeltect Limited at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer (VLU)
- What is being tested?
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 15 Jan 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
- Currently enrolled in or has been enrolled in another investigation device or drug trial in the last 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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:
Read more
- 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.
Read the 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)
- Being tested
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Keywords
- Venous Leg Ulcers
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Treatment | Experimental | The treatment group will also receive the same standard care, with the same type of compression bandages, 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. Receives: Device: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage area reduction per day
The weekly rate of wound area reduction (cm2) represented as a percentage, calculated by comparing the wound size at the end of the treatment (Aend) with the wound size at the start of treatment (Astart) and normalising for the length of time for treatment (T). (Aend - Astart)/Astart*100/T
Measured: From enrollment to the end of treatment 9 months
Secondary outcomes (2)
Average pressure applied to each patient
Tight Alright enables accurate real-time measurement of sub-bandage compression pressure (in mmHg). This outcome will measure the average pressure applied over the duration of treatment
Measured: From enrolment to the end of treatment 9 months
Percentage of patients healed
The percentage of patients healed completely within the study period
Measured: From enrolment to the end of treatment 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Jan 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feeltect Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Galway, CORRIB-CURAM Vascular Group, University of Galway, Galway, Ireland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268482
- Sponsor's protocol ID
- MERLIN251112WoundCompress
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07268482
- Acronym / sponsor ID
- MERLIN251112WoundCompress
- Conditions
- Venous Leg Ulcer (VLU)
- Keywords
- Venous Leg Ulcers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Feeltect LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University of Galway, CORRIB-CURAM Vascular Group, University of Galway, Galway, Ireland
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Treatment | Experimental | Device: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapyThe treatment group will also receive the same standard care, with the same type of compression bandages, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapyThe 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 | Device | Treatment |
Primary outcome
Percentage area reduction per day
Time frame: From enrollment to the end of treatment 9 months
The weekly rate of wound area reduction (cm2) represented as a percentage, calculated by comparing the wound size at the end of the treatment (Aend) with the wound size at the start of treatment (Astart) and normalising for the length of time for treatment (T). (Aend - Astart)/Astart*100/T
2 secondary outcomes
Average pressure applied to each patient
Time frame: From enrolment to the end of treatment 9 months
Percentage of patients healed
Time frame: From enrolment to the end of treatment 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy in people with Venous Leg Ulcer (VLU), run by Feeltect Limited at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Cameron (+353 87 184 0912, andrew.cameron@feeltect.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage area reduction per day (time frame: From enrollment to the end of treatment 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.