Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine on the Number of Hospital Days in Diabetic Patients (TELEPIED)
Primary Purpose
Diabetes Mellitus, Ulcer Foot
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Taking pictures
Visit at home
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus focused on measuring telemedicine
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Centre Hospitalier Sud-Francilien
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventionnal Group
"Telepied" Group
Arm Description
No intervention for this group. Patients will be followed by a usual care.
Patients will be followed by a nurse referring to ulcers of the diabetic foot.
Outcomes
Primary Outcome Measures
Number of hospitalization days related to diabetic foot ulcers after one year of follow-up
Secondary Outcome Measures
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
Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group
Ulcer recidivism rate in the Telepied group versus control group.
Frequency of ulceration
Duration of ulceration
Healing rate between the Telepied group and the control group
Amputation rate between the two groups
Patient satisfaction score
Full Information
NCT ID
NCT02986256
First Posted
November 24, 2016
Last Updated
June 4, 2020
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
1. Study Identification
Unique Protocol Identification Number
NCT02986256
Brief Title
Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine on the Number of Hospital Days in Diabetic Patients
Acronym
TELEPIED
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
May 12, 2020 (Actual)
Study Completion Date
May 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Ulcer Foot
Keywords
telemedicine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventionnal Group
Arm Type
No Intervention
Arm Description
No intervention for this group. Patients will be followed by a usual care.
Arm Title
"Telepied" Group
Arm Type
Experimental
Arm Description
Patients will be followed by a nurse referring to ulcers of the diabetic foot.
Intervention Type
Behavioral
Intervention Name(s)
Taking pictures
Intervention Description
Photograph of foot ulcer with transmission to referring nurse 1 time per week
Intervention Type
Behavioral
Intervention Name(s)
Visit at home
Intervention Description
Home visit by the referring nurse every 15 days
Primary Outcome Measure Information:
Title
Number of hospitalization days related to diabetic foot ulcers after one year of follow-up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Total direct care costs between the Telepied group and the control group
Description
hospitalization costs, transport costs, nursing costs, liberal nursing costs, material costs, number of consultations with the doctor
Time Frame
12 months
Title
Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group
Time Frame
12 months
Title
Ulcer recidivism rate in the Telepied group versus control group.
Time Frame
12 months
Title
Frequency of ulceration
Time Frame
12 months
Title
Duration of ulceration
Time Frame
12 months
Title
Healing rate between the Telepied group and the control group
Time Frame
12 months
Title
Amputation rate between the two groups
Time Frame
12 months
Title
Patient satisfaction score
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dured Dardari, MD
Organizational Affiliation
Centre Hospitalier Sud Francilien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Sud-Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91100
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine on the Number of Hospital Days in Diabetic Patients
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