Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes
ConditionVenous Leg Ulcer (VLU)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFeeltect Limited
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
DeviceThe 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 groups
40 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: TreatmentExperimental treatment 1 intervention
Trial outcomes
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
Time frame
From enrollment to the end of treatment 9 monthsSecondary outcomes
1
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
Time frame
From enrolment to the end of treatment 9 months2
Percentage of patients healed
The percentage of patients healed completely within the study period
Time frame
From enrolment to the end of treatment 9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Feeltect Limited
Lead sponsor
University of Galway
Collaborator
CORRIB-CURAM Vascular Group, University of Galway, Galway, Ireland
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: