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NCT Number: NCT07152717

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkview Center for Wound Healing

Fort Wayne, Indiana, 46805, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: FeelTect Tight Alright

Primary outcomes

  1. Percentage area reduction per day

    Time frame: 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 outcomes

  1. Average pressure

    Time frame: From enrollment to the end of treatment at 5 weeks

    The average pressure applied over the duration of treatment

  2. Percentage of patients healed

    Time frame: From enrollment to the end of treatment at 5 weeks

    The percentage of patients healed completely within the study period

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

(260) 347-8610

Sponsors and collaborators

Lead sponsor

Feeltect Limited

Industry

Collaborators

  • Parkview Health

Registry information

Official study title

Assessment of a Connected-health, Pressure Monitoring Technology for Improving Clinical Outcomes of Compression Therapy in the Treatment of Venous Leg Ulcers

Acronym: ACHIEVE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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