TELEWOUND study: multicenter evaluation of remote monitoring of chronic wounds with Pixacare across 7 French hospitals

A multicenter prospective randomized pragmatic study on 250 patients across 7 French reference hospitals, designed to assess the clinical non-inferiority, economic superiority and quality-of-life superiority of remote wound monitoring via Pixacare compared to conventional follow-up, at a national scale.

Study framework

Clinical multicenter study currently underway, coordinated by Dr. Dured Dardari, Sud Francilien Hospital. Sponsor: Pixacare. The study is conducted in 7 French hospitals spread across the country, representative of the diversity of the French hospital landscape:

• APHP Bichat – Claude Bernard (Paris) — diabetic foot ulcer
• Toulouse University Hospital — leg ulcer
• Strasbourg University Hospital — diabetic foot ulcer
• Besançon University Hospital — leg ulcer
• Angers University Hospital — leg ulcer
• Haguenau Hospital — diabetic foot ulcer
• Sud Francilien Hospital — diabetic foot ulcer

This geographic scale represents the largest evaluation of remote chronic wound monitoring ever conducted in France.

Timeline

• Total enrollment: 250 patients
• Enrollment period: 12 months
• Follow-up per patient: 12 months
• Total study duration: 18 months
• Status: study ongoing

Study design

Prospective, multicenter, interventional, comparative, randomized, pragmatic study. The pragmatic design aims to evaluate the solution under real-world conditions of use, as close as possible to routine clinical practice, across a diversity of territories, patient profiles and hospital organizations.

Centers and patients

The 7 participating centers cover the two main indications of chronic lower-limb wounds:

• Diabetic foot ulcer: APHP Bichat, Strasbourg University Hospital, Haguenau Hospital, Sud Francilien Hospital
• Leg ulcer: Toulouse University Hospital, Besançon University Hospital, Angers University Hospital

The study includes 250 adult patients with a single chronic lower-limb wound requiring regular dressing changes, followed in departments of endocrinology, diabetology, dermatology, vascular surgery or expert wound healing centers, depending on local organizations.

Objectives and endpoints

The primary objective is based on three hierarchical endpoints:

• Clinical non-inferiority at 16 weeks: wound healing kinetics
• Economic superiority at 12 months: cumulative direct wound-related costs (hospitalizations, transport, consultations)
• Superiority on wound-related quality of life

The study also evaluates several secondary endpoints: time to complete healing, recurrence rate, infection rate, rate of major and minor amputations, number and duration of hospitalizations, global quality of life, and patient and care-team satisfaction.

Why this study?

Patient-led remote monitoring of chronic wounds represents a complementary, more autonomous approach to existing models that rely on a healthcare professional (such as a community nurse) for data acquisition. Initial work conducted at Sud Francilien Hospital through the PIXAPROM study confirmed the feasibility of follow-up initiated and maintained by the patient.

TELEWOUND is the next step: validating at scale, across 7 centers with varied profiles (university and general hospitals, major and mid-sized cities, distinct organizational pathways), the clinical and economic effectiveness of this autonomous approach in 250 patients followed for 12 months. This multicenter diversity strengthens the external validity of the findings and their relevance for nationwide deployment.

The study aims to provide the evidence required by health authorities to assess the relevance of national reimbursement, in line with what has been obtained for five other chronic conditions in remote monitoring.

Keywords

Chronic wound, remote monitoring, multicenter study, randomized pragmatic trial, wound healing, quality of life, diabetic foot, leg ulcer, medico-economics, digital medical device