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Completed

NCT Number: NCT02986256

Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, 91100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Taking pictures

Behavioral

Photograph of foot ulcer with transmission to referring nurse 1 time per week

Visit at home

Behavioral

Home visit by the referring nurse every 15 days

Primary outcomes

  1. Number of hospitalization days related to diabetic foot ulcers after one year of follow-up

    Time frame: 12 months

Secondary outcomes

  1. Total direct care costs between the Telepied group and the control group

    Time frame: 12 months

    hospitalization costs, transport costs, nursing costs, liberal nursing costs, material costs, number of consultations with the doctor

  2. Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group

    Time frame: 12 months

  3. Ulcer recidivism rate in the Telepied group versus control group.

    Time frame: 12 months

  4. Frequency of ulceration

    Time frame: 12 months

  5. Duration of ulceration

    Time frame: 12 months

  6. Healing rate between the Telepied group and the control group

    Time frame: 12 months

  7. Amputation rate between the two groups

    Time frame: 12 months

  8. Patient satisfaction score

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: TELEPIED

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 8, 2016
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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