PIXAPROM study: feasibility of patient-led remote monitoring of chronic wounds with the Pixacare ePRO solution

A feasibility study conducted at Sud Francilien Hospital on 25 patients with chronic lower-limb wounds, designed to assess patient satisfaction and the integration of the Pixacare ePRO solution into routine clinical practice.

Study framework

Clinical study conducted at Sud Francilien Hospital, in the Department of Endocrinology, Diabetology and Metabolic Diseases. Principal investigator: Dr. Dured Dardari. Study completed, publication forthcoming.

Timeline

• Total study duration: 6 months
• ePRO usage per patient: 2 months
• Status: study completed, awaiting publication

Study design

Observational, single-center, prospective study. This design is well-suited to assessing the feasibility of a new digital solution in real-world conditions of use.

Center and patients

The study includes 25 patients with a single chronic lower-limb wound lasting more than 6 weeks, followed in the Department of Endocrinology, Diabetology and Metabolic Diseases at Sud Francilien Hospital.

Primary objective

The primary objective is to assess patient satisfaction after 2 months of using the Pixacare ePRO solution, through a questionnaire based on a 7-level Likert scale.

Secondary objectives

The study also explores:

• Healthcare professional satisfaction after 2 months of ePRO use by patients
• Patient engagement with the ePRO solution: adherence level and frequency of use
• Use of the Pixacare solution by healthcare professionals as part of follow-up
• The impact of sociodemographic characteristics (age, sex, education level, rural or urban area) on ePRO usage
• The impact of clinical characteristics, notably BMI, on ePRO usage

Why this study?

The Pixacare ePRO solution, designed for patients, enables simple, autonomous and continuous remote monitoring of chronic wound progression. Follow-up is initiated by the wound specialist during the initial consultation.

This study aims to assess the feasibility of integrating this digital solution into routine clinical practice, allowing remote monitoring of chronic wounds directly by patients. It complements clinical studies evaluating the medico-economic impact of remote monitoring by providing essential insight into real-world patient and clinician engagement with this type of device.

Keywords

Chronic wound, remote monitoring, ePRO, feasibility, patient satisfaction, digital medical device, diabetic foot

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