Telemonitoring of Chronic Wound Patients Using MyDerm, a Digital Solution: Feasibility Study (PIXAPROM)

Télésurveillance de Patients Porteurs d'Une Plaie Chronique à l'Aide d'Une Solution numérique MyDerm : étude de faisabilité

The aim of this study is to assess the feasibility of integrating myDerm for remote monitoring of chronic wounds into everyday practice, for patients over 18 years of age suffering from a single chronic wound of the lower limb (more than 6 weeks old).

Outcome measure 1 :

Evaluate patient satisfaction after 2 months of using the MyDerm solution.

Outcome measure 2 :

1. Evaluate caregiver satisfaction after 2 months of patient use of MyDerm solution.
2. Assess patient use (compliance, frequency) of MyDerm solution
3. Evaluate caregiver use of PIXACARE solution
4. Evaluate the impact of patients' socio-demographic characteristics (age, gender, level of education: primary/secondary/tertiary, rural/urban) on use of the MyDerm solution.
5. Evaluate the impact of patients' clinical characteristics on the use of the MyDerm solution.

Researchers will compare standard of care arm vs remote monitoring arm.

As part of remote monitoring, patients are invited to take photos of their wounds using their smartphone, and to answer a simple questionnaire to look for signs of complications. To assess satisfaction, the patient will complete a questionnaire after 2 months' use, using a 7-level Likert scale.

Study Overview

• Status: Completed
• Conditions: Lower Limb Wound; Single Chronic Wound

Detailed Description

Observational, monocentric study of patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of wound healing.

Clinical data will be collected by the investigating team during the primary consultation.

Patient satisfaction surveys will be sent in paper format to patients at the consultation scheduled at the end of the two-month follow-up period.

Caregiver" satisfaction surveys will be sent in paper format to caregivers at the end of the study.

The number of actions taken in response to an alert (by telephone, by message, organization of a physical consultation, organization of a teleconsultation, hospitalization) will be recorded in the post-alert action traceability form

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• France
  • France
    • Corbeil-Essonnes, France, France, 91106
      • Centre Hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of healing at hospital

Description

Inclusion Criteria:

• Patient with a single chronic wound of the lower limb (more than 6 weeks)
• Benefiting from the MyDerm digital wound-healing monitoring solution
• Patient aged 18 or over
• Informed patient who has not objected to the use of data

Exclusion Criteria:

• Patient refusing to participate in the study
• Patient included in a clinical trial
• Patient with a life expectancy shorter than the duration of the study
• Patient with cognitive impairment
• Inability to install or use the medical device for technical reasons (lack of internet connection, lack of 4G coverage or more, lack of smartphone)
• Patient requiring home hospital care
• Patient requiring Follow-up and rehabilitation care
• Pregnant or breast-feeding women
• Patient with a previously infected wound

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Telemonitoring; patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to questionnaire completed after two months of use	The satisfaction questionnaire using a 7-point Likert scale	At 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responses to the caregiver questionnaire completed at the end of the study using a 7-point Likert scale	The satisfaction questionnaire using a 7-point Likert scale	At 2 months
Patient use of the MyDerm solution	A. Number of patients with at least one telefile B. Total number of teledeposits generated per patient during the follow-up period C. Number of teledeposits per week per patient over the entire follow-up period (evolution of usage over the follow-up period)	At 2 months
The impact of patients' socio-demographic characteristics on use of the MyDerm solution	Number of patients with at least one telefile	At 2 months
The impact of patients' socio-demographic characteristics on use of the MyDerm solution	Total number of teledeposits generated per patient during follow-up period	AT 2 months
The impact of patients' socio-demographic characteristics on use of the MyDerm solution	Number of teledeposits per week per patient over the entire follow-up period (evolution of usage over the follow-up period)	AT 2 months
Use of PIXACARE solution by caregivers	Number of telemonitoring records opened per patient by the medical team during the follow-up period.	At 2 months
Use of PIXACARE solution by caregivers	Total number of alerts and number of alerts per patient during follow-up period	AT 2 months
Use of PIXACARE solution by caregivers	Number of actions by telephone related to an alert	At 2 months
Use of PIXACARE solution by caregivers	Number of e-mail related to an alert	At 2 months
Use of PIXACARE solution by caregivers	Number of organization of a physical consultation related to an alert	AT 2 months
Use of PIXACARE solution by caregivers	Number of organization of a teleconsultation	At 2 months
Use of PIXACARE solution by caregivers	Number of hospitalization related to an alert	At 2 months

Collaborators and Investigators

• Sponsor: Pixacare

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Actual): April 23, 2025
• Study Completion (Actual): October 16, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: patient satisfaction; telemonitoring; chronic wound; caregivers satisfaction
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction
• Other Study ID Numbers: 2024/001/Pixacare

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No