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

Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986256
• Other study ID #: 2016-A01136-45
• Status: Completed
• Phase: N/A
• Start date: January 4, 2017
• Est. completion date: May 12, 2020

Study information

• Verified date: June 2020
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 12, 2020
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Foot Ulcer
• Ulcer
• Ulcer Foot

Intervention

Behavioral:
• Taking pictures
Photograph of foot ulcer with transmission to referring nurse 1 time per week
• Visit at home
Home visit by the referring nurse every 15 days

Locations

Country	Name	City	State
France	Centre Hospitalier Sud-Francilien	Corbeil-Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hospitalization days related to diabetic foot ulcers after one year of follow-up		12 months
Secondary	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
Secondary	Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group		12 months
Secondary	Ulcer recidivism rate in the Telepied group versus control group.		12 months
Secondary	Frequency of ulceration		12 months
Secondary	Duration of ulceration		12 months
Secondary	Healing rate between the Telepied group and the control group		12 months
Secondary	Amputation rate between the two groups		12 months
Secondary	Patient satisfaction score		12 months