Venous Leg Ulcers (VLUs)
Conditions
Keywords
wound care, compression therapy, venous leg ulcers, remote monitoring, pressure sensing, connected health
Brief summary
This study evaluates the effectiveness of a connected-health, pressure monitoring technology (Tight Alright) to improve clinical outcomes of compression therapy in patients with venous leg ulcers (VLUs). Compression therapy is the standard of care for VLUs, but achieving and maintaining therapeutic sub-bandage pressure is challenging due to patient variability and lack of objective feedback. The Tight Alright system includes a wearable device that measures sub-bandage pressure at multiple points on the leg and transmits data to a mobile app and cloud database, enabling both guided compression application at the point-of-care and guided compression maintenance via remote monitoring. The study will be conducted at Parkview Noble Center for Wound Healing 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
Interventions
The Tight Alright system, developed by FeelTect Limited, consists of a wearable, pressure sensing device that measures sub-bandage pressure at three regions along the length of the lower leg. The wearable device transmits data wirelessly to a mobile app on a smart device, which then displays the data in real-time. The mobile app is also capable of transmitting data to a remote cloud database, via the internet, where it can be viewed on a remote dashboard (i.e., via a secure webpage).
Sponsors
Parkview Health
Feeltect Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient of Parkview Noble Center for Wound Healing * Adults 18+ with venous leg ulcers receiving compression therapy treatment prescribed by outpatient wound clinic. * Capable of using use a smart device * Owns a smart phone or device capable of downloading the Mobile App
Exclusion criteria
* \<18 years old * Unable to consent in English * Cellulitis in affected limb * Acute deep vein thrombosis in affected limb * Active malignancy in affected limb * Prisoners * Currently enrolled in or has been enrolled in another investigation device or drug trial in the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage area reduction per day | From enrollment to the end of treatment at 5 weeks | The daily rate of wound area reduction 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average pressure | From enrollment to the end of treatment at 5 weeks | The average pressure applied over the duration of treatment |
| Percentage of patients healed | From enrollment to the end of treatment at 5 weeks | The percentage of patients healed completely within the study period |
Countries
United States
Contacts
CONTACTBrooke Randol, MSN, RN, AGCNS-BC, CMSRN, CWS
Outcome results
None listed