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

Not Applicable

Completed

• Conditions: Ulcer Foot; Diabetes Mellitus
• Interventions: Behavioral: Taking pictures; Behavioral: Visit at home

• Registration Number: NCT02986256
• Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-08
• Study Start: 2017-01-04
• Primary Completion: 2020-05-12
• Study Completion: 2020-05-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Telepied" Group	Visit at home	Patients will be followed by a nurse referring to ulcers of the diabetic foot.
"Telepied" Group	Taking pictures	Patients will be followed by a nurse referring to ulcers of the diabetic foot.

Primary Outcome Measures

Name	Time	Method
Number of hospitalization days related to diabetic foot ulcers after one year of follow-up	12 months

Secondary Outcome Measures

Name	Time	Method
Total direct care costs between the Telepied group and the control group	12 months	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	12 months
Amputation rate between the two groups	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
Patient satisfaction score	12 months

Trial Locations

Locations (1)

Centre Hospitalier Sud-Francilien; 🇫🇷 Corbeil-Essonnes, France