Impact médico-économique de la télésurveillance Des Plaies Chroniques Avec Pixacare (IMETP)

Medico-Economic Impact of Telemonitoring Chronic Wounds With Pixacare

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Wounds
• Intervention / Treatment: Device: Pixacare

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre GUERRESCHI; Phone Number: +33 3 20 44 56 59; Email: pierre.guerreschi@chu-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Telemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs. The study ends 16 weeks after randomization.	Device: Pixacare; elemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs.
No Intervention: Control group; Conventional home follow-up of patients with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The study ends 16 weeks after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Wound-healing kinetics measured as the percentage reduction in wound area from baseline to end of study	16 weeks
To compare, between the two groups (telemonitoring and conventional follow-up), the weekly frequency of dressing changes	16 weeks
To compare, between the two groups (telemonitoring and conventional follow-up), the number of complications (infections, amputations).	16 weeks
To compare, between the two groups (telemonitoring and conventional follow-up), the number and cumulative duration of hospitalizations related to the wound.	16 weeks
Patient satisfaction score measured using a standardized digital satisfaction questionnaire integrated into the telemonitoring application	16 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Pixacare

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Home monitoring of chronic wounds; Pixacare
• Other Study ID Numbers: 2024_0237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No