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Ulcer Monitoring in Diabetes Mellitus (Telesaar)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Region of Southern Denmark
European Commission
Information provided by (Responsible Party):
Johnny Froekjaer, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Foot Ulcers Procedure: telemedicine consultations Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact Assessment by Introducing Telemedicine Consultations for Treatment of Diabetic Patients With Foot Ulcers in Region of Southern Denmark - Randomized Prospective Study
Study Start Date : April 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : November 2013

Arm Intervention/treatment
No Intervention: Control
Control group. Regular treatment.
Experimental: 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.
Other Name:

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01608425

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Contact: Benjamin S. Rasmussen, MD 004560774050

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South-west Hospital Recruiting
Esbjerg, Region of Southern Denmark, Denmark, 6700
Lillebaelt Hospital Recruiting
Kolding, Region of Southern Denmark, Denmark, 6000
Odense University Hospital Recruiting
Odense, Region of Southern Denmark, Denmark, 5000
Hospital South Jutland Recruiting
Soenderborg, Region of Southern Denmark, Denmark, 6400
Svendborg Hospital Recruiting
Svendborg, Region of Southern Denmark, Denmark, 5700
Hospital Lillebaelt Recruiting
Vejle, Region of Southern Denmark, Denmark, 7100
Sponsors and Collaborators
Johnny Froekjaer
Region of Southern Denmark
European Commission
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Johnny Froekjaer, Research responsible Chief Surgeon, Odense University Hospital Identifier: NCT01608425    
Other Study ID Numbers: Telesaar RH_3
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by Johnny Froekjaer, Odense University Hospital:
diabetic foot ulcer
ulcer monitoring
telemedicine consultations
cross-sectoral collaboration
Additional relevant MeSH terms:
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Foot Ulcer
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer