Chronic WoundsIMETPNCT07528950
Impact médico-économique de la télésurveillance Des Plaies Chroniques Avec Pixacare
A study testing Pixacare in people with Chronic Wounds, run by University Hospital, Lille.
Trial summary
The healing of chronic wounds extends over several months and accounts for 3% of the healthcare budget. Care networks capable of managing chronic wounds are heterogeneous, insufficient, and poorly coordinated across the country. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- Pixacare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult patient aged over 18 years
- Suffering from a single chronic wound, meaning a wound of any origin evolving for more than 6 weeks (diabetic foot ulcer, leg ulcer, or pressure ulcer) Patient seen in a specialized consultation at Lille University Hospital (CHU de Lille) for wound management (Diabetology Department, Plastic Surgery Department)
- A home-based wound-care protocol planned at the time of inclusion
- Patients owning a smartphone or a tablet at home
- Patient willing to comply with all study procedures and duration
- Patient who has provided written informed consent to participate in the study
- Patient covered by national health insurance
Who cannot join
- Minor patient
- Pregnant woman
- Patient hospitalized at the time of inclusion (except for home hospitalization, HAD)
- Multiple wounds
- Wound not appearing flat in the photograph
- A home nurse (RN) who is already following a patient from one study group may not follow another patient from the other group (control or telemonitoring) Inability to receive informed information, inability to participate in the full duration of the study, lack of health insurance coverage, refusal to sign the consent form
- Patient under guardianship or curatorship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Medico-Economic Impact of Telemonitoring Chronic Wounds With Pixacare
The healing of chronic wounds extends over several months and accounts for 3% of the healthcare budget. Care networks capable of managing chronic wounds are heterogeneous, insufficient, and poorly coordinated across the country.
The key levers identified to reduce the costs of chronic wound care are: reducing the number of consultations, shortening healing time, decreasing the weekly frequency of care, and enabling early management of complications through an alert system.
Read more
The Ministry of Health now aims to roll out telemonitoring into mainstream practice and to expand new telemonitoring structures to benefit new patients and new pathologies.
A review of the literature on telemedicine in general reveals numerous indicators confirming the strong potential of telemonitoring for chronic wounds to improve care efficiency.
It would allow specialized remote follow-up without adding workload for caregivers while reducing the number of in-person consultations. This expert oversight could lead to better-adapted treatments, resulting in faster healing and a reduced frequency of care.
Adverse developments and complications could also be detected and managed early through an alert system.
No controlled study using a digital tool with an alert system currently undergoing CE class IIa marking has yet effectively assessed the organizational and medical benefits of such telemonitoring for the management of chronic wounds. This is the objective of this research.
- Conditions
- Chronic Wounds
- Being tested
- Pixacare
- Keywords
- Home monitoring of chronic wounds, Pixacare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PixacareDevice
elemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol.
The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Telemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol.
The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs.
The study ends 16 weeks after randomization. Receives: Device: Pixacare |
| Control group | No intervention | Conventional home follow-up of patients with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The study ends 16 weeks after randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the superiority of a strategy based on home telemonitoring of patients, compared with a conventional follow-up strategy, in reducing the number of in-person consultations with specialized physicians among patients with chronic wounds
Measured: 16 weeks
Secondary outcomes (5)
Wound-healing kinetics measured as the percentage reduction in wound area from baseline to end of study
Measured: 16 weeks
To compare, between the two groups (telemonitoring and conventional follow-up), the weekly frequency of dressing changes
Measured: 16 weeks
To compare, between the two groups (telemonitoring and conventional follow-up), the number of complications (infections, amputations).
Measured: 16 weeks
To compare, between the two groups (telemonitoring and conventional follow-up), the number and cumulative duration of hospitalizations related to the wound.
Measured: 16 weeks
Patient satisfaction score measured using a standardized digital satisfaction questionnaire integrated into the telemonitoring application
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: Telemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs. The study ends 16 weeks after randomization. Control group: Conventional home follow-up of patients with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The study ends 16 weeks after randomization.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Pixacare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528950
- Sponsor's protocol ID
- 2024_0237
- Acronym
- IMETP
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-Economic Impact of Telemonitoring Chronic Wounds With Pixacare
- ClinicalTrials.gov ID
- NCT07528950
- Acronym / sponsor ID
- IMETP / 2024_0237
- Conditions
- Chronic Wounds
- Keywords
- Home monitoring of chronic wounds, Pixacare
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Pixacare
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 14 Apr 2026 (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 healing of chronic wounds extends over several months and accounts for 3% of the healthcare budget. Care networks capable of managing chronic wounds are heterogeneous, insufficient, and poorly coordinated across the country.
The key levers identified to reduce the costs of chronic wound care are: reducing the number of consultations, shortening healing time, decreasing the weekly frequency of care, and enabling early management of complications through an alert system.
The Ministry of Health now aims to roll out telemonitoring into mainstream practice and to expand new telemonitoring structures to benefit new patients and new pathologies.
A review of the literature on telemedicine in general reveals numerous indicators confirming the strong potential of telemonitoring for chronic wounds to improve care efficiency.
It would allow specialized remote follow-up without adding workload for caregivers while reducing the number of in-person consultations. This expert oversight could lead to better-adapted treatments, resulting in faster healing and a reduced frequency of care.
Adverse developments and complications could also be detected and managed early through an alert system.
No controlled study using a digital tool with an alert system currently undergoing CE class IIa marking has yet effectively assessed the organizational and medical benefits of such telemonitoring for the management of chronic wounds. This is the objective of this research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group: Telemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs. The study ends 16 weeks after randomization. Control group: Conventional home follow-up of patients with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The study ends 16 weeks after randomization.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: PixacareTelemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs. The study ends 16 weeks after randomization. |
| Control group | No intervention | –Conventional home follow-up of patients with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The study ends 16 weeks after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patient aged over 18 years
- Suffering from a single chronic wound, meaning a wound of any origin evolving for more than 6 weeks (diabetic foot ulcer, leg ulcer, or pressure ulcer) Patient seen in a specialized consultation at Lille University Hospital (CHU de Lille) for wound management (Diabetology Department, Plastic Surgery Department)
- A home-based wound-care protocol planned at the time of inclusion
- Patients owning a smartphone or a tablet at home
- Patient willing to comply with all study procedures and duration
Key exclusion criteria (7 listed)
- Minor patient
- Pregnant woman
- Patient hospitalized at the time of inclusion (except for home hospitalization, HAD)
- Multiple wounds
- Wound not appearing flat in the photograph
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pixacareelemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs. | Device | Experimental group |
Primary outcome
To demonstrate the superiority of a strategy based on home telemonitoring of patients, compared with a conventional follow-up strategy, in reducing the number of in-person consultations with specialized physicians among patients with chronic wounds
Time frame: 16 weeks
5 secondary outcomes
Wound-healing kinetics measured as the percentage reduction in wound area from baseline to end of study
Time frame: 16 weeks
To compare, between the two groups (telemonitoring and conventional follow-up), the weekly frequency of dressing changes
Time frame: 16 weeks
To compare, between the two groups (telemonitoring and conventional follow-up), the number of complications (infections, amputations).
Time frame: 16 weeks
To compare, between the two groups (telemonitoring and conventional follow-up), the number and cumulative duration of hospitalizations related to the wound.
Time frame: 16 weeks
Patient satisfaction score measured using a standardized digital satisfaction questionnaire integrated into the telemonitoring application
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pixacare in people with Chronic Wounds, run by University Hospital, Lille.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre GUERRESCHI (+33 3 20 44 56 59, pierre.guerreschi@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the superiority of a strategy based on home telemonitoring of patients, compared with a conventional follow-up strategy, in reducing the number of in-person consultations with specialized physicians among patients with chronic wounds (time frame: 16 weeks). 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 14 Apr 2026.