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| Name | Class |
|---|---|
| Parkview Health | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average pressure | The average pressure applied over the duration of treatment | From enrollment to the end of treatment at 5 weeks |
| Percentage of patients healed | The percentage of patients healed completely within the study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brooke Randol, MSN, RN, AGCNS-BC, CMSRN, CWS | Contact | (260) 347-8610 | Brooke.randol@parkview.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkview Center for Wound Healing | Fort Wayne | Indiana | 46805 | United States |
All IPD that underlie results in a publication
Beginning 1 month and ending 3 years after the publication of results
IPD will be shared if there is a legitimate concern, as assessed by the clinical team executing the study in Parkview Health, raised by other researchers about the validity of the data or the data processing methods, including statistical analysis. Brooke Randol will make the final decision on sharing IPD. An appropriate mechanism will be negotiated for sharing data, which may include a request for the proposed data analysis by other researchers and a data sharing agreement.
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| From enrollment to the end of treatment at 5 weeks |