Ulcer Monitoring in Diabetes Mellitus (Telesaar)
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.
Procedure: telemedicine consultations
|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|
- 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.
- 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.
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608425
|Contact: Benjamin S. Rasmussen, MDfirstname.lastname@example.org|
|Esbjerg, Region of Southern Denmark, Denmark, 6700|
|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, Region of Southern Denmark, Denmark, 5700|
|Vejle, Region of Southern Denmark, Denmark, 7100|
|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|