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

Not yet recruiting

• Conditions: Single Chronic Wound; Lower Limb Wound

• Registration Number: NCT06704087
• Lead Sponsor: Pixacare

Brief Summary

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.

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Study Start: 2024-12-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to questionnaire completed after two months of use	At 2 months	The satisfaction questionnaire using a 7-point Likert scale

Secondary Outcome Measures

Name	Time	Method
Responses to the caregiver questionnaire completed at the end of the study using a 7-point Likert scale	At 2 months	The satisfaction questionnaire using a 7-point Likert scale
Patient use of the MyDerm solution	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)
The impact of patients' socio-demographic characteristics on use of the MyDerm solution	AT 2 months	Number of teledeposits per week per patient over the entire follow-up period (evolution of usage over the follow-up period)
Use of PIXACARE solution by caregivers	At 2 months	Number of hospitalization related to an alert

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France