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Completed

NCT Number: NCT06704087

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Response to questionnaire completed after two months of use

    Time frame: At 2 months

    The satisfaction questionnaire using a 7-point Likert scale

Secondary outcomes

  1. Responses to the caregiver questionnaire completed at the end of the study using a 7-point Likert scale

    Time frame: At 2 months

    The satisfaction questionnaire using a 7-point Likert scale

  2. Patient use of the MyDerm solution

    Time frame: At 2 months

    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)

  3. The impact of patients' socio-demographic characteristics on use of the MyDerm solution

    Time frame: At 2 months

    Number of patients with at least one telefile

  4. The impact of patients' socio-demographic characteristics on use of the MyDerm solution

    Time frame: AT 2 months

    Total number of teledeposits generated per patient during follow-up period

  5. The impact of patients' socio-demographic characteristics on use of the MyDerm solution

    Time frame: AT 2 months

    Number of teledeposits per week per patient over the entire follow-up period (evolution of usage over the follow-up period)

  6. Use of PIXACARE solution by caregivers

    Time frame: At 2 months

    Number of telemonitoring records opened per patient by the medical team during the follow-up period.

  7. Use of PIXACARE solution by caregivers

    Time frame: AT 2 months

    Total number of alerts and number of alerts per patient during follow-up period

  8. Use of PIXACARE solution by caregivers

    Time frame: At 2 months

    Number of actions by telephone related to an alert

  9. Use of PIXACARE solution by caregivers

    Time frame: At 2 months

    Number of e-mail related to an alert

  10. Use of PIXACARE solution by caregivers

    Time frame: AT 2 months

    Number of organization of a physical consultation related to an alert

  11. Use of PIXACARE solution by caregivers

    Time frame: At 2 months

    Number of organization of a teleconsultation

  12. Use of PIXACARE solution by caregivers

    Time frame: At 2 months

    Number of hospitalization related to an alert

Sponsors and collaborators

Lead sponsor

Pixacare

Industry

Registry information

Official study title

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

Acronym: PIXAPROM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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