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

NCT07528950 | Not Yet Recruiting

• 1 other identifier: 2024_0237
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Wounds

Keywords

Home monitoring of chronic wounds; Pixacare

Outcome Measures

Primary Outcomes (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

  16 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Pixacare DEVICE

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• Minor patient
• Pregnant woman
• 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

Sponsors & Collaborators

• Pixacare: collaborator
• University Hospital, Lille: lead

Central Study Contacts

Pierre GUERRESCHI

CONTACT

+33 3 20 44 56 59; pierre.guerreschi@chu-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. 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.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share