Recruiting

Tight Alright

Sponsor:

Feeltect Limited

Code:

NCT07152717

Conditions

Venous Leg Ulcers (VLUs)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Conditions

Venous Leg Ulcers (VLUs)

Study ID

NCT07152717

Start date

Nov 6, 2025

Status verified date

Sep, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Brooke Randol, MSN, RN, AGCNS-BC, CMSRN, CWS

(260) 347-8610Brooke.randol@parkview.com

Locations

Parkview Center for Wound Healing

Recruiting

Fort Wayne, Indiana, United States, 46805

More Information

Sponsor

Feeltect Limited

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • wound care
  • compression therapy
  • venous leg ulcers
  • remote monitoring
  • pressure sensing
  • connected health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Feeltect Limited on 2026-09-09.