Research & Publications
To assess the real impact of our solutions, we conduct clinical studies in partnership with leading hospital departments. Our research focuses on:
The reliability of AI for the measurement and analysis of chronic wounds
The medico-economic benefits of remote monitoring to integrate chronic wounds into standard reimbursement pathways
Time savings enabled by digitized clinical documentation
Medico-economic impact of remote monitoring of chronic wounds with the Pixacare digital medical device.
Type of study
Monocentric prospective study, controlled versus conventional follow-up, randomized into 2 parallel arms, in open.
Services and Health Institution concerned
Department of endocrinology, department of dermatology, department of plastic and reconstructive surgery of the Lille University Hospital
Affected patients
100 patients suffering from a chronic wound (diabetic foot wound, leg ulcer or bedsores). The healing is managed by a specialized doctor with a treatment protocol carried out by an IDE at home. The patient follows up remotely via the remote repository
Objective and main evaluation criteria
Show the superiority of a strategy for telemonitoring patients at home compared to the conventional follow-up strategy in order to reduce the number of face-to-face consultations with the specialized physician in patients suffering from chronic wounds. → Number of face-to-face visits between randomization and after 16 weeks of follow-up.
Objectives and secondary criteria
Compare according to the 2 groups (remote monitoring and conventional monitoring):
• The kinetics of healing.
• The weekly frequency of dressing repairs.
• The number of complications (infections, amputations).
• The number and duration of cumulative hospitalizations related to the wound.
• Patient satisfaction.
Scientific justification
The healing of chronic wounds is a long process that represents 3% of the health budget. Dedicated care networks are inadequate and poorly coordinated. Remote monitoring would reduce costs by reducing the number of consultations, speeding up healing and optimizing the management of complications through an early warning system. The Ministry of Health encourages the deployment of these solutions. However, no controlled study has yet rigorously evaluated the organizational and medical impact of a CE certified digital device with an alert system. This study aims to fill this gap.
Remote monitoring of patients with chronic wounds with the Pixacare remote repository solution: a feasibility study
Type of study
Observational, monocentric, prospective study.
Services and Health Institution concerned
CH Sud Francilien : Department of Endocrinology, Diabetology and Metabolic Diseases
Affected patients
25 patients suffering from a single chronic wound in the lower limb for more than 6 weeks.
Objective and main evaluation criteria
Assessment of the patient satisfaction after 2 months of using the remote deposit solution, using a questionnaire based on a 7-level Likert scale.
Secondary goals
- Evaluate the Caregiver satisfaction after 2 months of use of telemetry by patients.
- Analyze the use of telemetry by patients: level of adherence, frequency of use.
- Evaluate the use of the Pixacare solution by caregivers as part of follow-up.
- Study the impact of patients' sociodemographic characteristics (age, sex, level of education: primary/secondary/tertiary, rural or urban areas) on the use of remote repository.
- Study the impact of clinical characteristics, including BMI, on the use of telemetry.
Scientific justification
The Pixacare remote repository solution, designed for patients, allows simple, autonomous and continuous remote monitoring of the evolution of chronic wounds.
Follow-up is initiated by the specialist doctor during the initial consultation.
This study aims to assess the feasibility of integrating this digital solution into current practice, to allow a remote monitoring of chronic wounds directly by patients.
Type of study
Multicentric, prospective, interventional, interventional, comparative, randomized, pragmatic.
Investigating centers and medical investigators
Angers University Hospital: Dr Nina Sigg, Dr Angélique Marchaud and IPA Clarisse Robin — Department of Dermatology and Venereology
Besancon University Hospital: Prof. Simon Rinckenbach — Department of Vascular and Endovascular Surgery
Bichat Hospital - Claude Bernard (AP-HP): Pr Louis Potier — Department of Diabetology and Endocrinology
CH of Haguenau: Dr Jérôme Schlegel — Internal Medicine and Diabetology Department
Strasbourg University Hospital: Prof. Laurence Kessler — Department of Endocrinology, Diabetes and Nutrition
CH Sud Francilien: Dr Dured Dardari and Prof. Alfred Penfornis — Department of Endocrino-Diabetology
Toulouse University Hospital: Dr Julie Malloizel-Delauney — Department of Vascular Medicine
Affected patients
250 patients suffering from a single chronic wound in the lower limb for more than 6 weeks.
Main Objectives
In patients suffering from chronic wounds in the lower extremities, the main objective is to demonstrate:
- La non-inferiority of the Pixacare remote surveillance solution on the healing kinetics at 4 months.
- La superiority of this solution on the cumulative length of hospitalization over 12 months.
- La superiority of the solution on the evolution of the quality of life related to the wound over 4 months.
Secondary goals
Medical secondary goals:
- Compare the average time to complete healing.
- Compare the rates of complete healing at 4, 8, and 12 months.
- Compare recidivism rates (same or other 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.
- Evaluate the evolution of the overall quality of life over 12 months.
Organizational secondary goals:
- Compare, at 12 months, the number of scheduled and unscheduled consultations (general medicine, specialties, paramedical care, including nursing).
- Compare the deadlines for getting appointments.
- Compare, at 12 months, the number of hospitalizations, emergency room visits and transfers to health 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 the satisfaction of health centers at 4, 8, and 12 months.
Secondary economic goals:
- Compare the direct costs accumulated over 12 months: hospitalizations, transport, nursing care, consultations.
Scientific justification
The Pixacare remote repository solution, designed for patients, allows simple and continuous remote monitoring of the evolution of wounds.
The follow-up is initiated by the physician specializing in chronic wounds during the initial consultation.
This study aims to objective to assess the feasibility of integrating this digital solution into current practice for the remote monitoring of chronic wounds by patients themselves.
Health institution concerned
CH of Haguenau: Vascular surgery department
Objectives
Evaluate two methods for measuring wound surface using smartphones:
- WoundTrack (WT): semi-automated method
- WoundSize (WS): automated method
These two approaches will be compared to the reference technique, digitized planimetry (PL), in order to assess their precision and reliability.
Population and methods
Monocentric open study, conducted on 42 patients between May and June 2023.
Three methods of wound surface measurement were used, each applied by two independent experts.
The statistical analysis took place in four steps:
- Multivariate variance analysis
- Evaluation of inter-expert correlation (precision of measurements)
- Analysis of agreement with the reference method (PL) (accuracy)
- Study of non-conformities: deviations > 20% compared to digitized planimetry, specifically for wounds of less than 8 cm²
Results
Out of 42 patients, 6 patients excluded (multi-planar wounds: 4; poorly defined contours: 2) - No significant difference in multivariate analysisCompare between the 2 groups (remote monitoring and conventional follow-up):
- Excellent accuracy for all three methods (ICC > 0.9)
- Excellent accuracy for WT and WS compared to PL, but WT better than WS
- For small wounds: WT does not differ significantly from PL; WS shows significant deviations.
Conclusion
Woundtrack is comparable to Digital Planimetry, both in terms of precision and accuracy, including for small wounds. It is an effective method, simple to implement, and less time-consuming. Woundsize presents more heterogeneous results, although they remain reliable. Its integration seems optimal via an algorithm such as “Proposal by AI → Validation by the clinician”.
Introduction
Medical photography, which is omnipresent in plastic surgery, provides essential information to the medical file. Smartphones have become the preferred tool for acquiring these photographs, but pose a data security problem. Moreover, photo management is often manual and time-consuming. The Pixacare software suite was therefore designed to meet this need securely. It includes a mobile application, a web application and an HDS server. The objective of the study was to calculate the time saved by the Pixacare application at the time of data acquisition.
Materials and methods
This prospective and monocentric study was carried out in two stages in order to time the acquisition times with the usual method and with the Pixacare mobile application. Each phase consisted of 89 patients recruited in 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
Photographic data acquisition time was divided by 3.77 (p < 0.001). With the usual method, the average acquisition time was 259 seconds compared to 69 seconds with the Pixacare application, saving 3 minutes and 10 seconds per patient.
Conclusion
The Pixacare software suite therefore saves the surgeon significant 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 health professionals and the effectiveness of secure messaging.
Objectives
The main objective of the study is to assess the reliability and reproducibility of remote photographic surveillance with the Pixacare tool for the postoperative follow-up of digital flaps., in particular by analysing the level of agreement between different observers.
The second objective is to measure the feasibility of extra-hospital follow-up using this same application, by examining the adherence of patients and paramedical staff.
Materials and methods
This descriptive, prospective and single-center study includes 27 patients to assess the remote monitoring of digital flaps via the Pixacare application.
Patients, monitored after digital reconstruction, use a QR code to transmit photos of their wound, taken by the nurses, to a secure file.
The main evaluation criteria are the agreement between observers for the analysis of the photos and the feasibility of this remote monitoring. The data is analyzed using the Kappa coefficient to measure the reliability of the evaluations, and the study receives the required ethical approval.
Results
The results show a strong inter-observer agreement (Kappa = 0.64), indicating that photographic analysis is reliable for the clinical follow-up of digital flaps. Patients show up 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 to smokers. These results support the idea that Pixacare could be an effective tool to space out in-person post-operative consultations, especially for patients who are far from specialized centers.
Introduction
As part of a prospective comparative intent-to-treat study, we evaluated the impact of remote monitoring of chronic wounds on the safety and consumption of health system resources.
From January to June 2023, 103 consecutive patients were treated either according to conventional follow-up (CF group, 61 patients), or with follow-up including remote wound monitoring (RM group, 42 patients).
Data was collected prospectively. The statistical analysis was carried out with the intention to treat, by evaluating the safety of treatment (mortality, major amputation, wound healing, use of emergency services), clinical outcomes (closure and wound closure time), organizational effectiveness (consultations, hospitalizations, use of unscheduled care) as well as the estimated cost of care.
Results
The use of remote monitoring did not alter safety criteria in the management of chronic wounds.
It allowed a reduction in healing time of 35 days (p = 0.05).
It led to a 55% decrease in hospital visits (p ≤ 0.01).
These factors led to an estimated reduction in the cost of care of 1,666 euros.
However, the observed decrease in the use of unscheduled care (emergency room visits, emergency hospitalizations) did not reach a threshold of statistical significance.
Remote monitoring of chronic wounds is therefore a safe and clinically effective approach, allowing a reduction in healing time compared to conventional follow-up. It reduces the need for hospital consultations and the overall cost of treatment, thus facilitating access to specialized healing care.
Key words
Chronic wound, diabetic foot ulcer, leg ulcer, bedsores, telemedicine