Studies & publications
To measure the real impact of our solutions, we conduct clinical studies in collaboration with several hospital departments. Our work focuses on :
The reliability of AI for the measurement and analysis of chronic wounds
The medico-economic benefits of telemonitoring for the reimbursement of chronic wounds
Digital documentation saves time
Medico-economic impact of remote monitoring of chronic wounds with the Pixacare digital medical device.
Type of study
Prospective, single-center, controlled study versus conventional follow-up, randomized in 2 parallel, open-label arms.
Services and health facilities concerned
Endocrinology Department, Dermatology Department, Plastic and Reconstructive Surgery Department, Lille University Hospital
Patients concerned
100 patients with chronic wounds (diabetic foot wounds, leg ulcers or pressure sores). Wound healing is managed by a specialist doctor, with a care protocol drawn up by a homecare nurse. Patients are monitored remotely via teledeposit.
Objective and primary endpoint
To show the superiority of a home telemonitoring strategy compared with the conventional follow-up strategy in reducing the number of face-to-face visits to the specialist physician in patients with chronic wounds. → Number of face-to-face visits between randomization and after 16 weeks of follow-up.
Objectives and secondary criteria
Compare the 2 groups (telemonitoring and conventional follow-up):
- Healing kinetics.
- Weekly frequency of dressing repairs.
- Number of complications (infections, amputations).
- Number and duration of wound-related hospitalizations.
- Patient satisfaction.
Scientific justification
Healing chronic wounds is a lengthy process that accounts for 3% of the healthcare budget. Dedicated care networks are insufficient and poorly coordinated. Telemonitoring could cut costs by reducing the number of consultations, speeding up healing and optimizing the management of complications thanks to an early warning system. The French Ministry of Health is encouraging the deployment of these solutions. However, no controlled study has yet rigorously assessed the organizational and medical impact of a CE-certified digital device with an early warning system. This study aims to fill this gap.
Remote monitoring of patients with chronic wounds with the Pixacare teledeposit solution: a feasibility study
Type of study
Observational, single-center, prospective study.
Services and health facilities concerned
CH Sud Francilien : Endocrinology, Diabetology and Metabolic Diseases Department
Patients concerned
25 patients suffering from a single chronic wound of the lower limb for more than 6 weeks.
Objective and primary endpoint
Assessment of patient satisfaction after 2 months' use of the telefile solution, using a questionnaire based on a 7-point Likert scale.
Secondary objectives
- Evaluate caregiver satisfaction after 2 months of patient teledeposit use.
- Analyze patients' use of teledeposit: level of adherence, frequency of use.
- Evaluate the use of the Pixacare solution by caregivers during follow-up.
- Study the impact of patients' socio-demographic characteristics (age, gender, level of education: primary/secondary/tertiary, rural/urban) on the use of tele-filing.
- Study the impact of clinical characteristics, particularly BMI, on the use of teledeposit.
Scientific justification
The Pixacare telemonitoring solution, designed for patients, enables simple, autonomous and continuous remote monitoring of the evolution of chronic wounds.
Monitoring is initiated by the specialist physician during the initial consultation.
This study aims to assess the feasibility of integrating this digital solution into routine practice, to enable remote monitoring of chronic wounds directly by patients.
Type of study
Multicentric, prospective, interventional, comparative, randomized, pragmatic.
Investigating centers and physicians
CHU d'Angers: Dr Nina Sigg, Dr Angélique Marchaud and IPA Clarisse Robin - Service de dermatologie et vénéréologie
CHU de Besançon: Pr Simon Rinckenbach - Service de chirurgie vasculaire et endovasculaire
Hôpital Bichat - Claude Bernard (AP-HP): Pr Louis Potier - Service de diabétologie et endocrinologie
CH de Haguenau: Dr Jérôme Schlegel - Internal Medicine and Diabetology Department
CHU de Strasbourg: Pr Laurence Kessler - Endocrinology, Diabetes and Nutrition Department
CH Sud Francilien: Dr Dured Dardari and Pr Alfred Penfornis - Endocrinology and Diabetology Department
CHU de Toulouse: Dr Julie Malloizel-Delauney - Vascular Medicine Department
Patients concerned
250 patients suffering from a single chronic wound of the lower limb for more than 6 weeks.
Main objectives
In patients with chronic wounds of the lower limbs, the main objective is to demonstrate:
- The non-inferiority of the Pixacare remote monitoring solution on healing kinetics at 4 months.
- The superiority of this solution on cumulative hospital stays over 12 months.
- The superiority of the solution on changes in wound-related quality of life over 4 months.
Secondary objectives
Secondary medical objectives :
- Compare average time to complete healing.
- Compare complete healing rates at 4, 8 and 12 months.
- Compare recurrence rates (same or different location) at 4, 8 and 12 months.
- Compare infection rates at 4, 8 and 12 months.
- Compare death rates at 4, 8 and 12 months.
- Compare amputation rates at 4, 8 and 12 months.
- Assess changes in overall quality of life over 12 months.
Secondary organizational objectives :
- Compare, at 12 months, the number of scheduled and unscheduled consultations (general medicine, specialties, paramedical care, including nursing).
- Compare appointment times.
- Compare, at 12 months, the number of hospitalizations, emergency room visits and transfers to care centers.
- Describe the use of the Pixacare digital solution in the interventional arm.
- Compare patient satisfaction and experience at 4, 8 and 12 months.
- Compare satisfaction at 4, 8 and 12 months.
Secondary economic objectives :
- Compare cumulative direct costs over 12 months: hospitalization, transport, nursing care, consultations.
Scientific justification
The Pixacare telemonitoring solution, designed for patients, enables simple, continuous remote monitoring of wound progress.
Monitoring is initiated by the chronic wound physician during the initial consultation.
The aim of this study is to assess the feasibility of integrating this digital solution into current practice for remote monitoring of chronic wounds by patients themselves.
Healthcare facility concerned
CH de Haguenau: Vascular surgery department
Objectives
Evaluating two methods of measuring wound surface from smartphones:
- WoundTrack (WT): semi-automated method
- WoundSize (WS): automated method
These two approaches will be compared with the reference technique, digitized planimetry (DP), to assess their accuracy and reliability.
Population and methods
Single-center, open-label study conducted on 42 patients between May and June 2023.
Three methods of wound surface measurement were used, each applied by two independent experts.
Statistical analysis was carried out in four stages:
- Multivariate analysis of variance
- Assessment of inter-expert correlation (measurement accuracy)
- Analysis of concordance with the reference method (PL) (accuracy)
- Study of non-conformities: deviations > 20% from digitized planimetry, specifically for wounds smaller than 8 cm².
Results
Out of 42 patients, 6 excluded (multi-planar wounds: 4; poorly defined contours: 2) - No significant difference in multivariate analysisComparison between the 2 groups (remote monitoring and conventional follow-up):
- Excellent precision for all three methods (ICC > 0.9)
- Excellent accuracy for WT and WS compared with PL, but WT outperforms WS
- For small wounds: WT does not differ significantly from PL; WS shows significant differences.
Conclusion
Woundtrack is comparable to Digital Planimetry in both precision and accuracy, even for small wounds. It's an effective method, easy to use and less time-consuming. Woundsize's results are more heterogeneous, though still reliable. Its integration seems optimal via a "Proposal by AI → Validation by clinician" type algorithm.
Introduction
Medical photography is ubiquitous in plastic surgery, providing essential information for medical records. Smartphones have become the preferred tool for acquiring these photographs, but this poses a data security problem. In addition, photo management is often manual and time-consuming. The Pixacare software suite has been designed to meet this need in complete security. It comprises a mobile application, a web application and an HDS server. The aim of the study was to calculate the time saved by the Pixacare application during data acquisition.
Materials and methods
This prospective, single-center study was carried out in two phases, in order to time acquisition times with the usual method and with the Pixacare mobile application. Each phase included 89 patients recruited from plastic and maxillofacial surgery consultations with four surgeons. The number of patients and the average number of photographs per patient were comparable for each practitioner in both phases.
Results
Le temps d’acquisition des données photographiques était divisé par 3,77 (p < 0,001). Avec la méthode usuelle, le temps d’acquisition moyen était de 259 secondes contre 69 secondes avec l’application Pixacare, faisant gagner 3 minutes et 10 secondes par patient.
Conclusion
The Pixacare software suite therefore saves the surgeon a significant amount of time, while ensuring appropriate data security. This study does not take into account the additional time saved by organizing medical meetings, the benefits of sharing photographs between healthcare professionals, and the effectiveness of secure messaging.
Objectives
The main objective of the study is to assess the reliability and reproducibility of remote photographic monitoring with the Pixacare tool for postoperative follow-up of digital flaps, by analyzing in particular the level of concordance between different observers.
The second objective is to measure the feasibility of out-of-hospital monitoring using the same application, by examining patient and paramedical staff compliance.
Materials and methods
This descriptive, prospective, single-center study includes 27 patients to evaluate remote monitoring of digital flaps via the Pixacare application.
Patients, followed after digital reconstruction, use a QR code to transmit photos of their wound, taken by nurses, to a secure file.
The main evaluation criteria are inter-observer agreement for photo analysis and the feasibility of remote monitoring. The data are analyzed using the Kappa coefficient to measure the reliability of the assessments, and the study has the requisite ethical approval.
Results
The results show high inter-observer agreement (Kappa = 0.64), indicating that photographic analysis is reliable for clinical follow-up of digital flaps. Patients were very satisfied with the follow-up, with an average score of 4.63 out of 5, demonstrating the value of such a system. Satisfaction is particularly high among non-smokers compared with smokers. These results support the idea that Pixacare could be an effective tool for spacing out face-to-face post-operative consultations, especially for patients far from specialist centers.
Introduction
As part of a prospective comparative intention-to-treat study, we assessed the impact of remote monitoring of chronic wounds on the safety and resource consumption of the healthcare system.
From January to June 2023, 103 consecutive patients were managed either according to conventional follow-up (CF group, 61 patients), or with follow-up including remote wound monitoring (RM group, 42 patients).
Data were collected prospectively. Statistical analysis was performed on an intention-to-treat basis, assessing treatment safety (mortality, major amputation, wound healing, use of emergency services), clinical outcomes (wound closure and closure time), organizational effectiveness (consultations, hospitalizations, use of unscheduled care) and estimated cost of care.
Results
The use of telemonitoring did not alter safety criteria in the management of chronic wounds.
It reduced healing time by 35 days (p = 0.05).
It led to a 55% reduction in hospital consultations (p ≤ 0.01).
These factors led to an estimated reduction in the cost of care of 1,666 euros.
The observed reduction in the use of unscheduled care (emergency room visits, emergency hospitalizations) did not, however, reach statistical significance.
Telemonitoring of chronic wounds is therefore a safe and clinically effective approach, enabling a reduction in healing time compared with conventional monitoring. It reduces the need for hospital consultations and the overall cost of treatment, thus facilitating access to specialized wound healing care.
Key words
Chronic wound, diabetic foot ulcer, leg ulcer, pressure sore, telemedicine