Pressure-Monitoring Technology for Leg Ulcer
(ACHIEVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new wearable device called Tight Alright, designed to manage leg ulcers caused by poor blood flow in veins. The device monitors the pressure on leg bandages, ensuring it remains optimal for healing. Participants will receive either standard care or use this new technology to determine if it accelerates healing and enhances treatment effectiveness. This trial suits individuals with venous leg ulcers who are using compression therapy and are comfortable with smartphone use. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve future treatment options.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this pressure-monitoring technology is safe for use in patients with venous leg ulcers?
Research shows that the Tight Alright technology is designed to manage compression therapy for venous leg ulcers (VLUs) more effectively. Although specific safety data for this device in human trials is unavailable, understanding the context is important. The trial phase is labeled "Not Applicable," indicating it involves devices or procedures considered less risky than new drugs.
Wearable devices like Tight Alright are generally non-invasive, meaning they don't enter the body, which usually results in fewer safety concerns. The device monitors the pressure under bandages and helps maintain the correct pressure using an app. This method could enhance compression therapy without introducing new risks.
Overall, while specific safety data is not available, the nature of the device suggests it is likely safe. Participants in the trial can expect regular monitoring and support to ensure safety and well-being.12345Why are researchers excited about this trial?
Unlike the standard options for treating leg ulcers, which generally involve basic compression wraps, the "Tight Alright" technology introduces a smart approach to managing these wounds. This new method uses pressure-monitoring technology to ensure that compression is applied consistently and effectively, even allowing for adjustments if pressure levels drop. Researchers are excited because this technology not only offers precision by guiding the reapplication of pressure but also supports convenient management through an app and web-dashboard, potentially reducing the need for frequent clinic visits. By empowering patients and caregivers with real-time data, this approach could significantly enhance healing outcomes and improve the quality of life for patients with leg ulcers.
What evidence suggests that this pressure-monitoring technology is effective for venous leg ulcers?
Research has shown that maintaining steady pressure is crucial for healing venous leg ulcers (VLUs). In this trial, participants in the Intervention Cohort will use Tight Alright, a wearable device designed to monitor the pressure under the bandage and guide the application of compression to targeted levels. Early results suggest that consistent pressure can accelerate healing and improve outcomes. This technology may help patients and caregivers apply the correct pressure, potentially enhancing wound healing. By providing real-time feedback, the device could also encourage patients to engage more actively in their care. Meanwhile, participants in the Control Cohort will receive their standard care, with the Tight Alright device data collected but blinded to clinicians and patients.15678
Are You a Good Fit for This Trial?
This trial is for patients with venous leg ulcers. Participants should be suitable for compression therapy and willing to use a mobile app and wearable device. Those unable to follow the study protocol or with conditions that might interfere with bandage pressure monitoring are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive compression therapy with or without the Tight Alright technology for venous leg ulcers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tight Alright
Trial Overview
The study tests 'Tight Alright', a connected-health system, against standard unguided compression therapy. It includes a wearable device measuring sub-bandage pressure, data transmission to an app, and remote monitoring aimed at improving healing rates in leg ulcer treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Feeltect Limited
Lead Sponsor
Parkview Health
Collaborator
Citations
Dressings and topical agents for treating venous leg ulcers
This review is a network meta‐analysis (NMA) which assesses the probability of complete ulcer healing associated with alternative dressings and topical agents.
Management of venous leg ulcers: Clinical practice ...
Management of venous leg ulcers: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum
Pressure-Monitoring Technology for Leg Ulcer (ACHIEVE ...
This study evaluates the effectiveness of a connected-health, pressure monitoring technology (Tight Alright) to improve clinical outcomes of compression ...
Endovenous management of venous leg ulcers
By 14 weeks, 81% of the small ulcers approximately ≤1 inch in diameter had healed. Larger ulcers were slower in healing (P < .001). Post-thrombotic etiology, ...
A Qualitative Study
The aim of this study was to understand which factors influence patients' adherence to venous leg ulcer treatment recommendations in primary ...
6.
app.trialscreen.org
app.trialscreen.org/trials/assessing-connected-health-pressure-monitoring-technology-improving-compression-trial-nct07152717Assessing Connected-Health, Pressure-Monitoring ...
Participants may experience faster wound healing, better compression therapy management, and more personalized care. Those in the intervention ...
7.
trial.medpath.com
trial.medpath.com/clinical-trial/730d24c47c988ba0/nct07152717-connected-health-pressure-monitoring-compression-therapy-venous-leg-ulcersAssessing Connected-Health, Pressure-Monitoring ... - MedPath
This study evaluates the effectiveness of a connected-health, pressure monitoring technology (Tight Alright) to improve clinical outcomes of compression ...
FeelTect company profile
Tight Alright is a pressure sensing device that can be easily and securely attached to a compression bandage, where it measures and monitors sub-bandage ...
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