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

NCT07268482 | Not Yet Recruiting

• 1 other identifier: MERLIN251112WoundCompress
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Leg Ulcer (VLU)

Keywords

Venous Leg Ulcers

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of treatment 9 months

Secondary Outcomes (2)

• Average pressure applied to each patient

  From enrolment to the end of treatment 9 months

• Percentage of patients healed

  From enrolment to the end of treatment 9 months

Study Arms (2)

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.

Device: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy

Interventions

A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy DEVICE

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled diabetes \[haemoglobin A1c (HbA1c) ≥12% in the last 3 months\]
• 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
• Currently enrolled in or has been enrolled in another investigation device or drug trial in the last 30 days

Sponsors & Collaborators

• Feeltect Limited: lead
• University of Galway: collaborator
• CORRIB-CURAM Vascular Group, University of Galway, Galway, Ireland: collaborator

Study Sites (1)

Merlin Park University Hospital

Galway, Galway, Ireland

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Andrew Cameron

CONTACT

+353 87 184 0912; andrew.cameron@feeltect.com

Sherif AH Sultan, MB BCh MCh MD FRCSI DEVS FISV

CONTACT

+35391720122; profsherifsultan@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)