NCT02986256

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

January 4, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2020

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

3.4 years

First QC Date

November 24, 2016

Last Update Submit

June 4, 2020

Conditions

Diabetes MellitusUlcer Foot

Keywords

telemedicine

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (8)

  • Total direct care costs between the Telepied group and the control group

    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

  • +3 more secondary outcomes

Study Arms (2)

Conventionnal Group

NO INTERVENTION

No intervention for this group. Patients will be followed by a usual care.

"Telepied" Group

EXPERIMENTAL

Patients will be followed by a nurse referring to ulcers of the diabetic foot.

Behavioral: Taking picturesBehavioral: Visit at home

Interventions

Taking picturesBEHAVIORAL

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

"Telepied" Group
Visit at homeBEHAVIORAL

Home visit by the referring nurse every 15 days

"Telepied" Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, 91100, France

Location

MeSH Terms

Conditions

Diabetes MellitusFoot Ulcer

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin Ulcer

Study Officials

  • Dured Dardari, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2016

First Posted

December 8, 2016

Study Start

January 4, 2017

Primary Completion

May 12, 2020

Study Completion

May 12, 2020

Last Updated

June 5, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)