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Ulcer Monitoring in Diabetes Mellitus (Telesaar)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Odense University Hospital
Sponsor:
Collaborators:
Region Southern Denmark
European Commission
Information provided by (Responsible Party):
Johnny Froekjaer, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01608425
First received: May 24, 2012
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Diabetes Mellitus
Foot Ulcers
Procedure: telemedicine consultations
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Admissions to hospital [ Time Frame: from time of inclusion until treatment completed, assessed up to 52 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The number of surgical procedures (incl. amputations) performed at hospital in realtion to the ulcer during the treatment period.


Secondary Outcome Measures:
  • Ulcer healing [ Time Frame: Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks ] [ Designated as safety issue: Yes ]
    The time from inclusion and start of treatment until ulcer is healed and treatment is stopped.


Estimated Enrollment: 400
Study Start Date: April 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: pleje.net

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608425

Contacts
Contact: Benjamin S. Rasmussen, MD 004560774050 benjamin.schnack.rasmussen@ouh.regionsyddanmark.dk

Locations
Denmark
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 Southern Denmark
European Commission
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Johnny Froekjaer, Research responsible Chief Surgeon, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01608425     History of Changes
Other Study ID Numbers: Telesaar RH_3
Study First Received: May 24, 2012
Last Updated: June 4, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
diabetic foot ulcer
ulcer monitoring
telemedicine consultations
cross-sectoral collaboration

Additional relevant MeSH terms:
Diabetes Mellitus
Foot Ulcer
Ulcer
Endocrine System Diseases
Foot Diseases
Glucose Metabolism Disorders
Leg Ulcer
Metabolic Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer

ClinicalTrials.gov processed this record on November 25, 2014