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

C

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

Status

Completed

Conditions

Diabetes Mellitus
Ulcer Foot

Treatments

Behavioral: Taking pictures
Behavioral: Visit at home

Study type

Interventional

Funder types

Other

Identifiers

NCT02986256
2016-A01136-45

Details and patient eligibility

About

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).

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

Conventionnal Group
No Intervention group
Description:
No intervention for this group. Patients will be followed by a usual care.
"Telepied" Group
Experimental group
Description:
Patients will be followed by a nurse referring to ulcers of the diabetic foot.
Treatment:
Behavioral: Visit at home
Behavioral: Taking pictures

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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