Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106
NCT Number: NCT06704087
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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Notify Me18 year and older
All sexes
Observational
Corbeil-Essonnes, France, 91106
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At 2 months
The satisfaction questionnaire using a 7-point Likert scale
Time frame: At 2 months
The satisfaction questionnaire using a 7-point Likert scale
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)
Time frame: At 2 months
Number of patients with at least one telefile
Time frame: AT 2 months
Total number of teledeposits generated per patient during follow-up period
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)
Time frame: At 2 months
Number of telemonitoring records opened per patient by the medical team during the follow-up period.
Time frame: AT 2 months
Total number of alerts and number of alerts per patient during follow-up period
Time frame: At 2 months
Number of actions by telephone related to an alert
Time frame: At 2 months
Number of e-mail related to an alert
Time frame: AT 2 months
Number of organization of a physical consultation related to an alert
Time frame: At 2 months
Number of organization of a teleconsultation
Time frame: At 2 months
Number of hospitalization related to an alert
Pixacare
Industry
Télésurveillance de Patients Porteurs d'Une Plaie Chronique à l'Aide d'Une Solution numérique MyDerm : étude de faisabilité
Acronym: PIXAPROM
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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