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Ulcer Monitoring in Diabetes Mellitus (Telesaar)

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ClinicalTrials.gov Identifier: NCT01608425
Recruitment Status : Unknown
Verified June 2013 by Johnny Froekjaer, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : May 31, 2012
Last Update Posted : June 5, 2013
Sponsor:
Collaborators:
Region of Southern Denmark
European Commission
Information provided by (Responsible Party):
Johnny Froekjaer, Odense University Hospital

Tracking Information
First Submitted Date  ICMJE May 24, 2012
First Posted Date  ICMJE May 31, 2012
Last Update Posted Date June 5, 2013
Study Start Date  ICMJE April 2011
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2012)
  • Admissions to hospital [ Time Frame: 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.
  • Surgical procedures [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2012)
Ulcer healing [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ulcer Monitoring in Diabetes Mellitus
Official Title  ICMJE Impact Assessment by Introducing Telemedicine Consultations for Treatment of Diabetic Patients With Foot Ulcers in Region of Southern Denmark - Randomized Prospective Study
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Foot Ulcers
Intervention  ICMJE 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.
Other Name: pleje.net
Study Arms  ICMJE
  • No Intervention: Control
    Control group. Regular treatment.
  • Experimental: Diabetes ulcer monitoring
    Receives a telemedicine intervention: Diabetes ulcer monitoring.
    Intervention: Procedure: telemedicine consultations
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 28, 2012)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01608425
Other Study ID Numbers  ICMJE Telesaar RH_3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnny Froekjaer, Odense University Hospital
Study Sponsor  ICMJE Johnny Froekjaer
Collaborators  ICMJE
  • Region of Southern Denmark
  • European Commission
Investigators  ICMJE
Study Director: Benjamin S. Rasmussen, MD Odense University Hospital
Principal Investigator: Johnny Froekjaer, MD Odense University Hospital
Study Chair: Knud B. Yderstraede, MD Odense University Hospital
PRS Account Odense University Hospital
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP