Diabetes MellitusTELEPIEDNCT02986256
Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine on the Number of Hospital Days in Diabetic Patients
A study testing Taking pictures and Visit at home in people with Diabetes Mellitus and Ulcer Foot, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 1 site in France.
Trial summary
The TELEPIED project aims to show that it is possible to reduce the number of hospitalization days of a patient with ulcers of the foot thanks to a new organization of care, based on the intervention of a coordinating nurse interacting with the nurse in charge of the patient thanks to a telemedicine tool allowing the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Ulcer Foot
- What is being tested?
- Taking pictures and Visit at home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2017to 12 May 2020
- 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
- Patients over 18 years
- Diabetic patients with foot ulcer
- Patient who agreed to participate in the study and sign free and informed consent
- Patient affiliated to a social security scheme
Who cannot join
- Pregnant Woman
- Patient deprived of liberty by a judicial or administrative decision or a person subject to a legal protection measure
- Patient already involved in another clinical trial protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study, Randomized in Parallel Groups, Evaluating the Consequences of the Management of Diabetic Foot Ulcers by Telemedicine Versus Conventional Monitoring on the Number of Hospital Days in Diabetic Patients
The TELEPIED project aims to show that it is possible to reduce the number of hospitalization days of a patient with ulcers of the foot thanks to a new organization of care, based on the intervention of a coordinating nurse interacting with the nurse in charge of the patient thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular follow-up of the evolution of the wound and adapting the support nurse to the home if necessary.
It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of the foot.
Read more
Patients included in the conventional group will be followed according to the usual practice Patients included in the "telepied" group will benefit from a personalized accompaniment by a nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting by delegating tasks of the investigator.
The patient will be visited by the referring nurse every 15 days. During these visits, the referring nurse will have the objective to evaluate the evolution of the ulcer as well as the care performed. This visit also allows a close personalized accompaniment for the patient, who will benefit from an education adapted to the characteristics of ulcer (discharge modalities for example ..) and its way of life.
Every patients will be followed for one year (12 months).
- Conditions
- Diabetes Mellitus, Ulcer Foot
- Being tested
- Taking pictures, Visit at home
- Keywords
- telemedicine
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking picturesBehavioural
Photograph of foot ulcer with transmission to referring nurse 1 time per week
Visit at homeBehavioural
Home visit by the referring nurse every 15 days
| Study group | Role | What they receive |
|---|---|---|
| Conventionnal Group | No intervention | No intervention for this group. Patients will be followed by a usual care. |
| "Telepied" Group | Experimental | Patients will be followed by a nurse referring to ulcers of the diabetic foot. Receives: Behavioral: Taking pictures; Behavioral: Visit at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalization days related to diabetic foot ulcers after one year of follow-up
Measured: 12 months
Secondary outcomes (8)
Total direct care costs between the Telepied group and the control group
hospitalization costs, transport costs, nursing costs, liberal nursing costs, material costs, number of consultations with the doctor
Measured: 12 months
Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group
Measured: 12 months
Ulcer recidivism rate in the Telepied group versus control group.
Measured: 12 months
Frequency of ulceration
Measured: 12 months
Duration of ulceration
Measured: 12 months
Healing rate between the Telepied group and the control group
Measured: 12 months
Amputation rate between the two groups
Measured: 12 months
Patient satisfaction score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start4 Jan 2017
- Primary completion12 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dured Dardari, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986256
- Sponsor's protocol ID
- 2016-A01136-45
- Acronym
- TELEPIED
- Status last verified
- Jun 2020
- First submitted
- 24 Nov 2016
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study, Randomized in Parallel Groups, Evaluating the Consequences of the Management of Diabetic Foot Ulcers by Telemedicine Versus Conventional Monitoring on the Number of Hospital Days in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02986256
- Acronym / sponsor ID
- TELEPIED / 2016-A01136-45
- Conditions
- Diabetes Mellitus, Ulcer Foot
- Keywords
- telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 8 Dec 2016 (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.
The TELEPIED project aims to show that it is possible to reduce the number of hospitalization days of a patient with ulcers of the foot thanks to a new organization of care, based on the intervention of a coordinating nurse interacting with the nurse in charge of the patient thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular follow-up of the evolution of the wound and adapting the support nurse to the home if necessary.
It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of the foot.
Patients included in the conventional group will be followed according to the usual practice Patients included in the "telepied" group will benefit from a personalized accompaniment by a nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting by delegating tasks of the investigator.
The patient will be visited by the referring nurse every 15 days. During these visits, the referring nurse will have the objective to evaluate the evolution of the ulcer as well as the care performed. This visit also allows a close personalized accompaniment for the patient, who will benefit from an education adapted to the characteristics of ulcer (discharge modalities for example ..) and its way of life.
Every patients will be followed for one year (12 months).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventionnal Group | No intervention | –No intervention for this group. Patients will be followed by a usual care. |
| "Telepied" Group | Experimental | Behavioral: Taking pictures, Behavioral: Visit at homePatients will be followed by a nurse referring to ulcers of the diabetic foot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years
- Diabetic patients with foot ulcer
- Patient who agreed to participate in the study and sign free and informed consent
- Patient affiliated to a social security scheme
Key exclusion criteria (3 listed)
- Pregnant Woman
- Patient deprived of liberty by a judicial or administrative decision or a person subject to a legal protection measure
- Patient already involved in another clinical trial protocol
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 |
|---|---|---|
| Taking picturesPhotograph of foot ulcer with transmission to referring nurse 1 time per week | Behavioural | "Telepied" Group |
| Visit at homeHome visit by the referring nurse every 15 days | Behavioural | "Telepied" Group |
Primary outcome
Number of hospitalization days related to diabetic foot ulcers after one year of follow-up
Time frame: 12 months
8 secondary outcomes
Total direct care costs between the Telepied group and the control group
Time frame: 12 months
Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group
Time frame: 12 months
Ulcer recidivism rate in the Telepied group versus control group.
Time frame: 12 months
Frequency of ulceration
Time frame: 12 months
Duration of ulceration
Time frame: 12 months
Healing rate between the Telepied group and the control group
Time frame: 12 months
Amputation rate between the two groups
Time frame: 12 months
Patient satisfaction score
Time frame: 12 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 5 Jun 2020.
- 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. This study is not recruiting at the moment.
Dured Dardari, MD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taking pictures and Visit at home in people with Diabetes Mellitus and Ulcer Foot, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète 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 3 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 5 Jun 2020. 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?
Number of hospitalization days related to diabetic foot ulcers after one year of follow-up (time frame: 12 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 5 Jun 2020.