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

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.

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Ulcer Foot
• Intervention / Treatment: Behavioral: Taking pictures; Behavioral: Visit at home

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Corbeil-Essonnes, France, 91100
    • Centre Hospitalier Sud-Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2017
• Primary Completion (Actual): May 12, 2020
• Study Completion (Actual): May 12, 2020

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimate): December 8, 2016

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: telemedicine
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 2016-A01136-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO