Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Ulcer Monitoring in Diabetes Mellitus (Telesaar)

4. juni 2013 opdateret af: Johnny Froekjaer

Impact Assessment by Introducing Telemedicine Consultations for Treatment of Diabetic Patients With Foot Ulcers in Region of Southern Denmark - Randomized Prospective Study

Telemedicine technology enables a direct and online text- and image communication in the treatment system from patient to the ulcer specialist. The technology is expected to have patient-related, economic and therapeutic benefits. The study is a substudy of a larger project entitled "Renewing Health", where also the economic and management aspects are highlighted. However, only few randomized prospective studies are conducted in this field. The purpose of the study is in a randomized prospective study, to assess the impact of the introduction of the telemedicine technology as consultation form between ulcer-nurses in the primary sector and the wound clinics at the hospitals in the region. It is assessed whether the technology can be adopted without incurring the patient a risk. The study aims to perform an impact analysis of the introduction of new technologies for telemedicine wound monitoring in the treatment of diabetic foot ulcers through different studies.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Through randomized and prospective studies the project will show whether a telemedicine approach to wound care can be used as an alternative to traditional attendance at a wound clinic and document whether this consultation form provides a greater patient-satisfaction and cost savings. The project will document that telemedicine is equivalent to conventional outpatient attendance from a therapeutic aspect in terms of number of hospitalizations, number of extra controls, acute interventions and wound healing.

The project is also investigating the extent of time spent on the personnel side using telemedicine consultations compared with conventional outpatient appearances.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

400

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
    • Region of Southern Denmark
      • Esbjerg, Region of Southern Denmark, Danmark, 6700
        • Rekruttering
        • South-west Hospital
      • Kolding, Region of Southern Denmark, Danmark, 6000
        • Rekruttering
        • Lillebaelt Hospital
      • Odense, Region of Southern Denmark, Danmark, 5000
        • Rekruttering
        • Odense University Hospital
      • Soenderborg, Region of Southern Denmark, Danmark, 6400
        • Rekruttering
        • Hospital South Jutland
      • Svendborg, Region of Southern Denmark, Danmark, 5700
        • Rekruttering
        • Svendborg Hospital
      • Vejle, Region of Southern Denmark, Danmark, 7100
        • Rekruttering
        • Hospital Lillebaelt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Having diabetic foot ulcer
  • Referred for out-patient clinic treatment by general practitioner
  • Referred for out-patient clinic treatment by a surgical department
  • Living in Region of Southern Denmark

Exclusion Criteria:

  • Psychiatric disorder
  • Dementia
  • Chronic alcohol abuse which can affect compliance
  • Other disorder then diabetes mellitus that have caused foot ulcer (rheumatoid arthritis or arthritis urica)
  • Serious kidney disease which requires dialysis
  • Previous foot ulcer - which was part of the study
  • Expected healing within 2-4 weeks where only one control (final) is expected

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
Control group. Regular treatment.
Eksperimentel: Diabetes ulcer monitoring
Receives a telemedicine intervention: Diabetes ulcer monitoring.
Procedure: telemedicine consultations
Replacing 2 out of 3 patient visits to out-patient clinic at hospital with treatment at home from visiting nurse and telemedicine consultations with the specialist doctor.
Andre navne:
  • pleje.net

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Admissions to hospital
Tidsramme: from time of inclusion until treatment completed, assessed up to 52 weeks
The number of admissions, incl, beddays, to hospital relating to ulcer treatment for each randomised patient during the treatment period.
from time of inclusion until treatment completed, assessed up to 52 weeks
Surgical procedures
Tidsramme: from time of inclusion until completed treatment, assessed up to 52 weeks
The number of surgical procedures (incl. amputations) performed at hospital in realtion to the ulcer during the treatment period.
from time of inclusion until completed treatment, assessed up to 52 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ulcer healing
Tidsramme: Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks
The time from inclusion and start of treatment until ulcer is healed and treatment is stopped.
Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johnny Froekjaer

Samarbejdspartnere

European Commission
Region of Southern Denmark

Efterforskere

  • Studieleder: Benjamin S. Rasmussen, MD, Odense University Hospital
  • Ledende efterforsker: Johnny Froekjaer, MD, Odense University Hospital
  • Studiestol: Knud B. Yderstraede, MD, Odense University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2011

Primær færdiggørelse (Forventet)

1. juni 2013

Studieafslutning (Forventet)

1. november 2013

Datoer for studieregistrering

Først indsendt

24. maj 2012

Først indsendt, der opfyldte QC-kriterier

28. maj 2012

Først opslået (Skøn)

31. maj 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Telesaar RH_3

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus

Kliniske forsøg med telemedicine consultations

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malaysia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner