Venous Leg Ulcers (VLUs)ACHIEVENCT07152717
Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment
A study testing A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy in people with Venous Leg Ulcers (VLUs), run by Feeltect Limited at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers (VLUs)
- What is being tested?
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Parkview Center for Wound Healing
Fort Wayne, Indiana, 46805
About this study
Official title: Assessment of a Connected-health, Pressure Monitoring Technology for Improving Clinical Outcomes of Compression Therapy in the Treatment of Venous Leg Ulcers
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)
- Being tested
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Keywords
- wound care, compression therapy, venous leg ulcers, remote monitoring, pressure sensing, connected health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapyDevice
Also called FeelTect Tight Alright
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 group | Role | What they receive |
|---|---|---|
| Control Cohort | Other | 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. Receives: Device: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy |
| Intervention Cohort | Experimental | 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. Receives: Device: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage area reduction per day
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
Measured: From enrollment to the end of treatment at 5 weeks
Secondary outcomes (2)
Average pressure
The average pressure applied over the duration of treatment
Measured: From enrollment to the end of treatment at 5 weeks
Percentage of patients healed
The percentage of patients healed completely within the study period
Measured: From enrollment to the end of treatment at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start6 Nov 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcers (VLUs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feeltect Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parkview Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152717
- Sponsor's protocol ID
- NUR25-0409WoundCompress
- Acronym
- ACHIEVE
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Connected-health, Pressure Monitoring Technology for Improving Clinical Outcomes of Compression Therapy in the Treatment of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT07152717
- Acronym / sponsor ID
- ACHIEVE / NUR25-0409WoundCompress
- Conditions
- Venous Leg Ulcers (VLUs)
- Keywords
- wound care, compression therapy, venous leg ulcers, remote monitoring, pressure sensing, connected health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Feeltect LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Parkview Health
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Cohort | Other | Device: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapyPatients 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. |
| Intervention Cohort | Experimental | Device: A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- <18 years old
- Unable to consent in English
- Cellulitis in affected limb
- Acute deep vein thrombosis in affected limb
- Active malignancy in affected limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapyAlso: FeelTect Tight AlrightThe 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). | Device | Control Cohort, Intervention Cohort |
Primary outcome
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
2 secondary outcomes
Average pressure
Time frame: From enrollment to the end of treatment at 5 weeks
Percentage of patients healed
Time frame: From enrollment to the end of treatment at 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy in people with Venous Leg Ulcers (VLUs), run by Feeltect Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brooke Randol, MSN, RN, AGCNS-BC, CMSRN, CWS ((260) 347-8610, Brooke.randol@parkview.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage area reduction per day (time frame: From enrollment to the end of treatment at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.