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

NCT06704087 | Completed

• 1 other identifier: 2024/001/Pixacare
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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. 1.Evaluate caregiver satisfaction after 2 months of patient use of MyDerm solution.
2. 2.Assess patient use (compliance, frequency) of MyDerm solution
3. 3.Evaluate caregiver use of PIXACARE solution
4. 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. 5.Evaluate the impact of patients' clinical characteristics on the use of the MyDerm solution.

Conditions

Single Chronic Wound; Lower Limb Wound

Keywords

chronic wound; telemonitoring; patient satisfaction; caregivers satisfaction

Outcome Measures

Primary Outcomes (1)

• Response to questionnaire completed after two months of use

  The satisfaction questionnaire using a 7-point Likert scale

  At 2 months

Secondary Outcomes (12)

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

  At 2 months

• Patient use of the MyDerm solution

  At 2 months

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

  At 2 months

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

  AT 2 months

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

  AT 2 months

Study Arms (1)

Telemonitoring

patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of healing.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pixacare: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

There is no biospecimen

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start: February 6, 2025
• Primary Completion: April 23, 2025
• Study Completion: October 16, 2025
• Last Updated: December 12, 2025

Record last verified: 2024-11

Locations

FR (1)