Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment

Conditions

• Venous Leg Ulcers (VLUs)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Oct 1, 2025

Status verified

Aug 2025

Primary completion

Sep 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Control Cohort
  Patients will receive their normal standard of care and usual pattern of wound care visits from the treating provider. The Tight Alright device will be placed under the compression wrap by a study investigator and data will be transmitted but blinded to clinicians and patients. All patients in the Control Cohort will complete the study prior to initiating patients into the Intervention Cohort.
• Experimental: Intervention Cohort
  Patients will receive their normal standard of care with the addition of using the Tight Alright technology, applied by a study investigator, to guide the application of compression to targeted pressures. The Tight Alright technology will be used to monitor pressure in the home setting, using the app (point-of-care) and web-dashboard (remotely), and to guide the reapplication of targeted pressure. If pressures drop below 40 mmHg at the B sensor, for two consecutive readings, reapplications will be considered. Reapplication of compression using a top-up layer can be delivered in a number of different ways, including additional patient visits, patient, informal caregiver, self-management via teleconsultation, or independent self-management.

Primary Outcome Measure

Percentage area reduction per day [ Time Frame: From enrollment to the end of treatment at 5 weeks ]

Central Contacts

• Brooke Randol, MSN, RN, AGCNS-BC, CMSRN, CWS
  (260) 347-8610
  [email protected]

Locations (1)

Find similar trials in Fort Wayne, IN

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