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

NCT07268482 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-05

No results posted yet for this study

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)

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • University of Galway

    collaborator OTHER

  • CORRIB-CURAM Vascular Group, University of Galway, Galway, Ireland

    collaborator UNKNOWN

  • Feeltect Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-09-30
Completion
2026-10-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07268482 on ClinicalTrials.gov