Resident of Languedoc-roussillonDOMOPLAIESNCT02545374
Medico-economic Evaluation of a Project of Wounds by a Remote Network
A study testing Telemedicine in people with Resident of Languedoc-roussillon and Carrying a Chronic Wound, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds compared with the usual care(with or without CICAT-LR Network). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resident of Languedoc-roussillon, Carrying a Chronic Wound
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Mar 2016
- Phase
- Interventional
- 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
Who may be able to join
- Being adult
- Taken up residence on the Languedoc-Roussillon
- Patient carrying a wound with healing or improvement objective (wound closure or the appearance of 40% of granulation)
- Informed consent signed,
- Patient member of the Security Social
- Patient having a visiting nurse.
Who cannot join
- Patient in vital or functional emergency situation during the first call or during the consultation
- Tumoral wound
- dialysis patient
- Arteritis of stage 4 and not revascularizable
- Absence of regular doctor and visiting nurse
- patient refusal
Show all 12Show fewer
- Refusal of one of the health professionals participating in the pathology care
- Anybody incapable to communicate and to answer the questions
- Pregnant or nursing woman
- Subject deprived of freedom by court or administrative order
- Major subject protected by the law
- For the patients in telemedicine: refusal of the collaboration agreement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medico-economic Evaluation of the DOMOPLAIES Project by the CICAT-LR Network
Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds compared with the usual care(with or without CICAT-LR Network).
- Being tested
- Telemedicine, Control
- Keywords
- chronic wound, tablet, telemedicine, wounds consultation, Smartphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | In the telemedicine arm, all patients will be supported by Telemedicine protocol according to the development of telemedicine in the region.
The use of teleconsultation allows the couple expert doctor / nurse expert to perform a complex of wound assessment consultation and / or chronic. The use of telemedicine allows for acts of telecare, when the nurse applicant sought a remote support of an expert nurse (under the responsibility of a doctor) for the realization of an act. The use of tele-expertise enables physicians to remotely bring special expertise to improve patient care. Receives: Other: Telemedicine |
| Control | Active comparator | In the control arm, patient care depend on his home, as is currently the case:
* If it is in the action zone of Cicat-LR network, then it will be supported by an expert nurse of the network that are physically visit the patient's home-lon is the protocols established by the network.
* If not, then it will be supported by the customs of the attending physician and nursing teams who follow him. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of healed chronic wounds during a telemedicine care
Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
Measured: Six months after inclusion
Rate of healed chronic wounds during a usual medical care
Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
Measured: Six months after inclusion
Secondary outcomes (7)
Result to the questionnaire on the quality of life: EQ-5D
Compare the quality of life of patients with chronic wounds during a telemedicine coverage versus during a usual medical care, thanks to the EQ-5D quality life scale.
Measured: Six months after inclusion
A measure of the costs of the management of the disease
A measure of the costs of the management of the disease (consumer care, hospitalization, transport ...)
Measured: Seven months after the inclusion of the last patient
A measure of the costs of the intervention assessed
A measure of the costs of the intervention assessed (investment, maintenance, training ...).
Measured: Seven months after the inclusion of the last patient
The total healing time
Measured: Six months after inclusion
The decrease in centimeters of the wound surface to 6 months
Measured: Six months after inclusion
The response time between making an appointment and support
Measured: Six months after inclusion
The mortality rate within 6 months
Measured: Six months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resident of Languedoc-roussillonStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545374
- Sponsor's protocol ID
- 9250
- Acronym
- DOMOPLAIES
- Status last verified
- Apr 2016
- First submitted
- 2 Sep 2015
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Teot L, Geri C, Lano J, Cabrol M, Linet C, Mercier G. Complex Wound Healing Outcomes for Outpatients Receiving Care via Telemedicine, Home Health, or Wound Clinic: A Randomized Controlled Trial. Int J Low Extrem Wounds. 2020 Jun;19(2):197-204. doi: 10.1177/1534734619894485. Epub 2019 Dec 18.
PubMed 31852312
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of the DOMOPLAIES Project by the CICAT-LR Network
- ClinicalTrials.gov ID
- NCT02545374
- Acronym / sponsor ID
- DOMOPLAIES / 9250
- Keywords
- chronic wound, tablet, telemedicine, wounds consultation, Smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Sep 2015 (estimated)
- 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.
Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds compared with the usual care(with or without CICAT-LR Network).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: TelemedicineIn the telemedicine arm, all patients will be supported by Telemedicine protocol according to the development of telemedicine in the region. The use of teleconsultation allows the couple expert doctor / nurse expert to perform a complex of wound assessment consultation and / or chronic. The use of telemedicine allows for acts of telecare, when the nurse applicant sought a remote support of an expert nurse (under the responsibility of a doctor) for the realization of an act. The use of tele-expertise enables physicians to remotely bring special expertise to improve patient care. |
| Control | Active comparator | Other: ControlIn the control arm, patient care depend on his home, as is currently the case: * If it is in the action zone of Cicat-LR network, then it will be supported by an expert nurse of the network that are physically visit the patient's home-lon is the protocols established by the network. * If not, then it will be supported by the customs of the attending physician and nursing teams who follow him. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being adult
- Taken up residence on the Languedoc-Roussillon
- Patient carrying a wound with healing or improvement objective (wound closure or the appearance of 40% of granulation)
- Informed consent signed,
- Patient member of the Security Social
Key exclusion criteria (12 listed)
- Patient in vital or functional emergency situation during the first call or during the consultation
- Tumoral wound
- dialysis patient
- Arteritis of stage 4 and not revascularizable
- Absence of regular doctor and visiting nurse
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 |
|---|---|---|
| Telemedicine | Other | Telemedicine |
| Control | Other | Control |
Primary outcome
Rate of healed chronic wounds during a telemedicine care
Time frame: Six months after inclusion
Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
Rate of healed chronic wounds during a usual medical care
Time frame: Six months after inclusion
Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
7 secondary outcomes
Result to the questionnaire on the quality of life: EQ-5D
Time frame: Six months after inclusion
A measure of the costs of the management of the disease
Time frame: Seven months after the inclusion of the last patient
A measure of the costs of the intervention assessed
Time frame: Seven months after the inclusion of the last patient
The total healing time
Time frame: Six months after inclusion
The decrease in centimeters of the wound surface to 6 months
Time frame: Six months after inclusion
The response time between making an appointment and support
Time frame: Six months after inclusion
The mortality rate within 6 months
Time frame: Six months after inclusion
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 Jun 2026.
- Results publication: PubMed 31852312Teot L, Geri C, Lano J, Cabrol M, Linet C, Mercier G. Complex Wound Healing Outcomes for Outpatients Receiving Care via Telemedicine, Home Health, or Wound Clinic: A Randomized Controlled Trial. Int J Low Extrem Wounds. 2020 Jun;19(2):197-204. doi: 10.1177/1534734619894485. Epub 2019 Dec 18.
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?
A study testing Telemedicine in people with Resident of Languedoc-roussillon and Carrying a Chronic Wound, run by University Hospital, Montpellier 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 6 inclusion and 12 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 Jun 2026. 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?
Rate of healed chronic wounds during a telemedicine care (time frame: Six months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02545374, which also lists 1 linked publication.
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 Jun 2026.