Clinical trial NCT02986256: Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine on the Number of Hospital Days in Diabetic Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Ulcer Foot
Keywords: telemedicine
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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

Primary outcomes:
measure: Number of hospitalization days related to diabetic foot ulcers after one year of follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Total direct care costs between the Telepied group and the control group
timeFrame: 12 months
measure: Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group
timeFrame: 12 months
measure: Ulcer recidivism rate in the Telepied group versus control group.
timeFrame: 12 months
measure: Frequency of ulceration
timeFrame: 12 months
measure: Duration of ulceration
timeFrame: 12 months
measure: Healing rate between the Telepied group and the control group
timeFrame: 12 months
measure: Amputation rate between the two groups
timeFrame: 12 months
measure: Patient satisfaction score
timeFrame: 12 months
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud-Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Dured Dardari, MD
role: PRINCIPAL_INVESTIGATOR
References: