Ulcer Monitoring in Diabetes Mellitus (Telesaar)
|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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Foot Ulcers||Procedure: telemedicine consultations||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|