Clinical trial NCT06704087: Telemonitoring of Chronic Wound Patients Using MyDerm, a Digital Solution: Feasibility Study
Official title: Télésurveillance de Patients Porteurs d'Une Plaie Chronique à l'Aide d'Une Solution numérique MyDerm : étude de faisabilité
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Single Chronic Wound
Lower Limb Wound
Keywords: chronic wound
telemonitoring
patient satisfaction
caregivers satisfaction
Lead sponsor: Pixacare
Sponsor class: INDUSTRY
First posted: 2024-11-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Response to questionnaire completed after two months of use
timeFrame: At 2 months
Secondary outcomes:
measure: Responses to the caregiver questionnaire completed at the end of the study using a 7-point Likert scale
timeFrame: At 2 months
measure: Patient use of the MyDerm solution
timeFrame: At 2 months
measure: The impact of patients' socio-demographic characteristics on use of the MyDerm solution
timeFrame: At 2 months
measure: The impact of patients' socio-demographic characteristics on use of the MyDerm solution
timeFrame: AT 2 months
measure: The impact of patients' socio-demographic characteristics on use of the MyDerm solution
timeFrame: AT 2 months
measure: Use of PIXACARE solution by caregivers
timeFrame: At 2 months
measure: Use of PIXACARE solution by caregivers
timeFrame: AT 2 months
measure: Use of PIXACARE solution by caregivers
timeFrame: At 2 months
measure: Use of PIXACARE solution by caregivers
timeFrame: At 2 months
measure: Use of PIXACARE solution by caregivers
timeFrame: AT 2 months
measure: Use of PIXACARE solution by caregivers
timeFrame: At 2 months
measure: Use of PIXACARE solution by caregivers
timeFrame: At 2 months
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References: