A randomized controlled clinical study conducted at Lille University Hospital on 100 patients with chronic wounds, designed to assess the medico-economic impact of remote monitoring through Pixacare compared to conventional follow-up.
Study framework
Clinical study currently underway at Lille University Hospital (CHU de Lille), coordinated by Prof. Pierre Guerreschi, full professor of plastic and reconstructive surgery. Sponsor: Lille University Hospital. Funding: France 2030 national investment plan (Experimentation Hub program).
Timeline
- Protocol filed: September 2025
- Enrollment phase: 12 months
- Follow-up per patient: 16 weeks
- Total study duration: 16 months
- First results expected: during 2027
Study design
Prospective, randomized, controlled clinical study versus conventional follow-up, with two parallel arms. This design represents the highest level of evidence in clinical research.
Centers and patients
The study draws on three specialized departments at Lille University Hospital (plastic and reconstructive surgery, dermatology, diabetic foot) and includes 100 patients with chronic wounds: diabetic foot ulcers, leg ulcers, or pressure ulcers. Each patient is followed for 16 weeks.
Primary objective
The study evaluates whether remote monitoring via Pixacare can reduce the number of in-person consultations with the wound specialist, compared to conventional follow-up, without compromising the quality of care.
Secondary objectives
The study also compares the following parameters between the two groups:
- Wound healing kinetics
- Frequency of dressing changes
- Number of complications (infections, amputations)
- Number and duration of wound-related hospitalizations
- Patient quality of life, measured with validated instruments
Why this study?
Chronic wounds affect 2.5 million people in France and account for up to 3% of healthcare system budgets. Remote monitoring is identified as a major lever to improve follow-up quality while reducing costs, but no controlled study had yet rigorously assessed the contribution of a digital device featuring an automated alert system in this indication. The IMETP study fills this gap and aligns with the broader strategy for deploying remote monitoring supported by the French Ministry of Health.
Keywords
Chronic wound, remote monitoring, telemedicine, digital medical device, randomized controlled trial, medico-economics
Références
- IMETP study — Medico-economic impact of remote monitoring of chronic wounds with Pixacare. Prospective randomized controlled trial, Lille University Hospital. Coordinator: Prof. Pierre Guerreschi. Study ongoing, first results expected during 2027.