Single Chronic WoundPIXAPROMNCT06704087
Telemonitoring of Chronic Wound Patients Using MyDerm, a Digital Solution: Feasibility Study
An observational study of Single Chronic Wound and Lower Limb Wound, run by Pixacare at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single Chronic Wound, Lower Limb Wound
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2025to 16 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of healing at hospital
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patient requiring Follow-up and rehabilitation care
- Pregnant or breast-feeding women
- Patient with a previously infected wound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Télésurveillance de Patients Porteurs d'Une Plaie Chronique à l'Aide d'Une Solution numérique MyDerm : étude de faisabilité
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 :
Read more
Evaluate patient satisfaction after 2 months of using the MyDerm solution.
Outcome measure 2 :
- Evaluate caregiver satisfaction after 2 months of patient use of MyDerm solution.
- Assess patient use (compliance, frequency) of MyDerm solution
- Evaluate caregiver use of PIXACARE solution
- Evaluate the impact of patients' socio-demographic characteristics (age, gender, level of education: primary/secondary/tertiary, rural/urban) on use of the MyDerm solution.
- 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.
Read the 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
- Conditions
- Single Chronic Wound, Lower Limb Wound
- Keywords
- chronic wound, telemonitoring, patient satisfaction, caregivers satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of healing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to questionnaire completed after two months of use
The satisfaction questionnaire using a 7-point Likert scale
Measured: At 2 months
Secondary outcomes (12)
Responses to the caregiver questionnaire completed at the end of the study using a 7-point Likert scale
The satisfaction questionnaire using a 7-point Likert scale
Measured: At 2 months
Patient use of the MyDerm solution
- 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)
Measured: At 2 months
The impact of patients' socio-demographic characteristics on use of the MyDerm solution
Number of patients with at least one telefile
Measured: At 2 months
The impact of patients' socio-demographic characteristics on use of the MyDerm solution
Total number of teledeposits generated per patient during follow-up period
Measured: AT 2 months
The impact of patients' socio-demographic characteristics on use of the MyDerm solution
Number of teledeposits per week per patient over the entire follow-up period (evolution of usage over the follow-up period)
Measured: AT 2 months
Use of PIXACARE solution by caregivers
Number of telemonitoring records opened per patient by the medical team during the follow-up period.
Measured: At 2 months
Use of PIXACARE solution by caregivers
Total number of alerts and number of alerts per patient during follow-up period
Measured: AT 2 months
Use of PIXACARE solution by caregivers
Number of actions by telephone related to an alert
Measured: At 2 months
Use of PIXACARE solution by caregivers
Number of e-mail related to an alert
Measured: At 2 months
Use of PIXACARE solution by caregivers
Number of organization of a physical consultation related to an alert
Measured: AT 2 months
Use of PIXACARE solution by caregivers
Number of organization of a teleconsultation
Measured: At 2 months
Use of PIXACARE solution by caregivers
Number of hospitalization related to an alert
Measured: At 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start6 Feb 2025
- Primary completion23 Apr 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Chronic WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pixacare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704087
- Sponsor's protocol ID
- 2024/001/Pixacare
- Acronym
- PIXAPROM
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Télésurveillance de Patients Porteurs d'Une Plaie Chronique à l'Aide d'Une Solution numérique MyDerm : étude de faisabilité
- ClinicalTrials.gov ID
- NCT06704087
- Acronym / sponsor ID
- PIXAPROM / 2024/001/Pixacare
- Conditions
- Single Chronic Wound, Lower Limb Wound
- Keywords
- chronic wound, telemonitoring, patient satisfaction, caregivers satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PixacareIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Evaluate caregiver satisfaction after 2 months of patient use of MyDerm solution.
- Assess patient use (compliance, frequency) of MyDerm solution
- Evaluate caregiver use of PIXACARE solution
- Evaluate the impact of patients' socio-demographic characteristics (age, gender, level of education: primary/secondary/tertiary, rural/urban) on use of the MyDerm solution.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | – | –patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of healing at hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response to questionnaire completed after two months of use
Time frame: At 2 months
The satisfaction questionnaire using a 7-point Likert scale
12 secondary outcomes
Responses to the caregiver questionnaire completed at the end of the study using a 7-point Likert scale
Time frame: At 2 months
Patient use of the MyDerm solution
Time frame: At 2 months
The impact of patients' socio-demographic characteristics on use of the MyDerm solution
Time frame: At 2 months
The impact of patients' socio-demographic characteristics on use of the MyDerm solution
Time frame: AT 2 months
The impact of patients' socio-demographic characteristics on use of the MyDerm solution
Time frame: AT 2 months
Use of PIXACARE solution by caregivers
Time frame: At 2 months
Use of PIXACARE solution by caregivers
Time frame: AT 2 months
Use of PIXACARE solution by caregivers
Time frame: At 2 months
Use of PIXACARE solution by caregivers
Time frame: At 2 months
Use of PIXACARE solution by caregivers
Time frame: AT 2 months
Use of PIXACARE solution by caregivers
Time frame: At 2 months
Use of PIXACARE solution by caregivers
Time frame: At 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Chronic Wound and Lower Limb Wound, run by Pixacare at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to questionnaire completed after two months of use (time frame: At 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.