Impact médico-économique de la télésurveillance Des Plaies Chroniques Avec Pixacare (NCT07528950) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact médico-économique de la télésurveillance Des Plaies Chroniques Avec Pixacare
100 participantsStarted 2026-04
Plain-language summary
The healing of chronic wounds extends over several months and accounts for 3% of the healthcare budget. Care networks capable of managing chronic wounds are heterogeneous, insufficient, and poorly coordinated across the country.
The key levers identified to reduce the costs of chronic wound care are: reducing the number of consultations, shortening healing time, decreasing the weekly frequency of care, and enabling early management of complications through an alert system.
The Ministry of Health now aims to roll out telemonitoring into mainstream practice and to expand new telemonitoring structures to benefit new patients and new pathologies.
A review of the literature on telemedicine in general reveals numerous indicators confirming the strong potential of telemonitoring for chronic wounds to improve care efficiency.
It would allow specialized remote follow-up without adding workload for caregivers while reducing the number of in-person consultations. This expert oversight could lead to better-adapted treatments, resulting in faster healing and a reduced frequency of care.
Adverse developments and complications could also be detected and managed early through an alert system.
No controlled study using a digital tool with an alert system currently undergoing CE class IIa marking has yet effectively assessed the organizational and medical benefits of such telemonitoring for the management of chronic wounds. This is the objective of this research.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patient aged over 18 years
* Suffering from a single chronic wound, meaning a wound of any origin evolving for more than 6 weeks (diabetic foot ulcer, leg ulcer, or pressure ulcer) Patient seen in a specialized consultation at Lille University Hospital (CHU de Lille) for wound management (Diabetology Department, Plastic Surgery Department)
* A home-based wound-care protocol planned at the time of inclusion
* Patients owning a smartphone or a tablet at home
* Patient willing to comply with all study procedures and duration
* Patient who has provided written informed consent to participate in the study
* Patient covered by national health insurance
Exclusion Criteria:
* Minor patient
* Pregnant woman
* Patient hospitalized at the time of inclusion (except for home hospitalization, HAD)
* Multiple wounds
* Wound not appearing flat in the photograph
* A home nurse (RN) who is already following a patient from one study group may not follow another patient from the other group (control or telemonitoring) Inability to receive informed information, inability to participate in the full duration of the study, lack of health insurance coverage, refusal to sign the consent form
* Patient under guardianship or curatorship
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To demonstrate the superiority of a strategy based on home telemonitoring of patients, compared with a conventional follow-up strategy, in reducing the number of in-person consultations with specialized physicians among patients with chronic wounds