Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine on the Number of Hospital Days in Diabetic Patients

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Diabetes Mellitus, Ulcer Foot

Intervention / Treatment
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* Behavioral: Taking pictures
* Behavioral: Visit at home


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventionnal Group<br>No intervention for this group. Patients will be followed by a usual care. | |
| Experimental: Telepied Group<br>Patients will be followed by a nurse referring to ulcers of the diabetic foot. | Behavioral: Taking pictures<br>* Photograph of foot ulcer with transmission to referring nurse 1 time per week<br>Behavioral: Visit at home<br>* Home visit by the referring nurse every 15 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalization days related to diabetic foot ulcers after one year of follow-up |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group |  | 12 months | 
| Ulcer recidivism rate in the Telepied group versus control group. |  | 12 months | 
| Frequency of ulceration |  | 12 months | 
| Duration of ulceration |  | 12 months | 
| Healing rate between the Telepied group and the control group |  | 12 months | 
| Amputation rate between the two groups |  | 12 months | 
| Patient satisfaction score |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine